Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical external fixation device and its reprocessing. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML applications in medical devices.

Therapeutic

Yes
The device is used for "treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects," which are therapeutic applications.

Diagnostic

No
The device is described as an external fixation system used for the management of bone fractures and orthopedic surgery, which is a therapeutic purpose, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly lists various hardware components (frames, clamps, rods, pins, etc.) made of metal alloys, plastic, and composites, and the performance studies focus on bench and laboratory testing of these physical devices and their reprocessing.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description and Intended Use: The provided information clearly describes the device as an external fixation device used for skeletal fixation and treatment of fractures, osteotomy, etc. This is a surgical device used directly on the patient's body to stabilize bones.
No Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform diagnostic tests.

The device described is a surgical implant/device used for orthopedic procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

Product codes

KTT, KTW, JEC

Device Description

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
Biocompatibility
Validation of reprocessing
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K870961, K962808, K970713

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

0

K012634

long

510(k) Summary of Safety and Effectiveness

| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Don Selvey
Vice President, Regulatory Affairs and Quality Assurance
(480) 763-5300 |
| Date of preparation: | 8 August 2001 |
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/Multiple
Component and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and
Accessories |

Reprocessed device(s):

ﻤﺴﺎﺑﻪ

| MANUFACTURER | MODEL
NUMBER | DESCRIPTION |--------------------------------|----------- | SMITH & NEPHEW RICHARDS, INC. | 100100 | SMITH & NEPHEW RICHARDS, INC. | 100101 | SMITH & NEPHEW RICHARDS, INC. | 100102 | SMITH & NEPHEW RICHARDS, INC. | 100103 | SMITH & NEPHEW RICHARDS, INC. | 100105 | SMITH & NEPHEW RICHARDS, INC. | 100106 | SMITH & NEPHEW RICHARDS, INC. | 100107 | SMITH & NEPHEW RICHARDS, INC. | 100108 | SMITH & NEPHEW RICHARDS, INC. | 100110 | SMITH & NEPHEW RICHARDS, INC. | 100600 | SMITH & NEPHEW RICHARDS, INC. | 100700 | SMITH & NEPHEW RICHARDS, INC. | 100900 | SMITH & NEPHEW RICHARDS, INC. | 100901 | SMITH & NEPHEW RICHARDS, INC. | 101302 | SMITH & NEPHEW RICHARDS, INC. | 101307 | SMITH & NEPHEW RICHARDS, INC. | 101309 | SMITH & NEPHEW RICHARDS, INC. | 101351 | SMITH & NEPHEW RICHARDS, INC. | 101352 | SMITH & NEPHEW RICHARDS, INC. | 101355 | | | SMITH & NEPHEW RICHARDS, INC | 10-1357 | SMITH & NEPHEW RICHARDS, INC. | 10-1358 | SMITH & NEPHEW RICHARDS, INC. | 10-1359 | SMITH & NEPHEW RICHARDS, INC. | 101402 | SMITH & NEPHEW RICHARDS, INC. | 101600 | SMITH & NEPHEW RICHARDS, INC. | 101602 | SMITH & NEPHEW RICHARDS, INC. | 101800 | SMITH & NEPHEW RICHARDS, INC. | 101810 | SMITH & NEPHEW RICHARDS, INC. | 101900 | SMITH & NEPHEW RICHARDS, INC. | 102300 | SMITH & NEPHEW RICHARDS, INC. | 103405 | SMITH & NEPHEW RICHARDS, INC. | 103406 | SMITH & NEPHEW RICHARDS, INC. | 10-345 | SMITH & NEPHEW RICHARDS, INC. | 103451 | SMITH & NEPHEW RICHARDS, INC. | 201004 | SMITH & NEPHEW RICHARDS, INC. | 201300 | SMITH & NEPHEW RICHARDS, INC. | 7110-1362 | SMITH & NEPHEW RICHARDS, INC. | 71033002 | SMITH & NEPHEW RICHARDS, INC. | 71033006 | SMITH & NEPHEW RICHARDS, INC. | 10-0550 | SMITH & NEPHEW RICHARDS, INC. | 10-0601 | SMITH & NEPHEW RICHARDS, INC. | 10-0800 | SMITH & NEPHEW RICHARDS, INC. | 10-1303 | SMITH & NEPHEW RICHARDS, INC. | 10-1304 | SMITH & NEPHEW RICHARDS, INC. | 10-1306 | SMITH & NEPHEW RICHARDS, INC. | 10-1353 | SMITH & NEPHEW RICHARDS, INC. | 10-1356 | SMITH & NEPHEW RICHARDS, INC. | 10-1500 | SMITH & NEPHEW RICHARDS, INC. | 10-1700 | SMITH & NEPHEW RICHARDS, INC. | 10-1702 | SMITH & NEPHEW RICHARDS, INC. | 10-1901 | SMITH & NEPHEW RICHARDS, INC. | 10-2300 | SMITH & NEPHEW RICHARDS, INC. | 10-2301 | SMITH & NEPHEW RICHARDS, INC. | 10-2303 | SMITH & NEPHEW RICHARDS, INC. | 10-2304 | SMITH & NEPHEW RICHARDS, INC. | 10-2501 | SMITH & NEPHEW RICHARDS, INC. | 10-2706 | SMITH & NEPHEW RICHARDS, INC. | 10-2721 | SMITH & NEPHEW RICHARDS, INC. | 10-3195 | SMITH & NEPHEW RICHARDS, INC. | 10-3202 | SMITH & NEPHEW RICHARDS, INC. | 10-3203 | SMITH & NEPHEW RICHARDS, INC. | 10-3302 | SMITH & NEPHEW RICHARDS, INC. | 10-3310 | SMITH & NEPHEW RICHARDS, INC. | 10-3451 | SMITH & NEPHEW RICHARDS, INC. | 10-3453 | SMITH & NEPHEW RICHARDS, INC. | 20-1700 | SMITH & NEPHEW RICHARDS, INC. | 7101-2005 | Predicate device(s): | ------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ILIZAROV TELESCOPIC ROD |
| ILIZAROV TELESCOPIC ROD |
| ILIZAROV TELESCOPIC ROD |
| ILIZAROV TELESCOPIC ROD |
| ILIZAROV GRAD. TELESCOPIC ROD |
| ILIZAROV GRAD. TELESCOPIC ROD |
| ILIZAROV GRAD. TELESCOPIC ROD |
| ILIZAROV GRAD. TELESCOPIC ROD |
| ILIZAROV PART. THREADED ROD |
| ILIZAROV WIRE FIXATION BOLT SLOTTED |
| ILIZAROV WIRE FIXATION BOLT SLOTTED |
| ILIZAROV THREADED SOCKET |
| ILIZAROV SOCKET, THREADED |
| ILIZAROV HALF RING |
| ILIZAROV HALF RING |
| ILIZAROV HALF RING |
| ILIZAROV COMPOSITE HALF RING |
| ILIZAROV COMPOSITE HALF RING |
| ILIZAROV COMPOSITE HALF RING |
| |
| ILIZAROV COMPOSITE HALF RING |
| ILIZAROV COMPOSITE HALF RING |
| ILIZAROV COMPOSITE HALF RING |
| ILIZAROV SUPPORT MASCULINE END |
| ILIZAROV EXTERNAL FIXATION HINGE |
| ILIZAROV LOW PROFILE MALE HINGE |
| ILIZAROV SHORT CONNECTION PLATE 3-HOLE |
| ILIZAROV STRAIGHT BAR 2-HOLE |
| ILIZAROV TWISTED BAR 2-HOLE |
| ILIZAROV ROD, THREADED |
| ILIZAROV CENTERING SLEEVE |
| ILIZAROV SQUARE WASHER |
| ILIZAROV EXTERNAL FIXATION DEVICE |
| ILIZAROV CUBE (1-HOLE) |
| ILIZAROV ARCH |
| ILIZAROV OBLIQUE SUPPORT CONNECTION |
| ILIZAROV COMPOSITE RING |
| EXTERNAL TIBIAL FIXATOR |
| EXTERNAL TIBIAL FIXATOR |
| CONNECTION BOLT |
| WIRE FIXATION BOLT |
| BUSHING |
| HALF METAL RING |
| METAL HALF RING |
| HALF METAL RING |
| COMPOSITE HALF RING |
| COMPOSITE HALF RING |
| POST FEMALE END 2 HOLES |
| HINGE FEMALE END |
| HINGE FEMALE END |
| TWIST PLATE 3 HOLE |
| THREADED ROD |
| THREADED ROD |
| THREADED ROD |
| THREADED ROD |
| HINGE 90 DEG. |
| FIXATION BOLT WASHER |
| SLOTTED WASHER |
| CONNECTION BOLT |
| CONNECTION BOLT |
| CONNECTION BOLT |
| 4PT. D/COUNTER |
| HEX NUT |
| CUBE 1 HOLE |
| CUBE 3 HOLE |
| CONICAL WASHER COUPLE |
| NYLON INSERT NUT |
href="https://510k.innolitics.com/search/K870961" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K870961 | Smith & Nephew Richards, Inc., External Fixation
|
href="https://510k.innolitics.com/search/K962808" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K962808 | Smith & Nephew Richards, Ilizarov External
|
href="https://510k.innolitics.com/search/K970713" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K970713 | Smith & Nephew Richards Compass® Proximal
|
| External fixation devices are specially designed frames, clamps, rods,
wire fixations, fixation
connecting bars and screws used
and reconstructive, as well as
used include metal alloys,
are chosen to address a wide
as well as to allow for the
|
| External Fixation Devices are intended to be used for the fixation of
of the femur; for fusion of a joint;
cutting the bone, for fixation of
as a guide pin for insertion of other
the skin so that a pulling force or
system; and others may be used
bone reconstructions, as a guide pin
it may be implanted through the skin
be applied to the skeletal system. |
| Reprocessed external fixation devices are indicated for use in patients
oand treatment of fractures,
deformities, fracture revision,
lengthening, correction of bony
bony or soft tissue defects. |
| The design, materials, and intended use of the Reprocessed External
predicate devices. The
External Fixation Device is
that the same standard
and sizes are utilized. There are
clinical applications, patient
or method of operation. |
| Bench and laboratory testing was conducted to demonstrate
of the Reprocessed External
|
| Biocompatibility
|

1

KO12634

2

34

Sopy

ﭘﺮ

Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.

3

K012634

40Fy

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices as described herein.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird with three lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2002

Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K012623, K012634, K012645, K012648 Trade Name: Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, KTW, JEC Dated: April 3, 2002 Received: April 4, 2002

Dear Mr. Selvey:

We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements concerning your devices in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

5

Page 2 - Mr. Don Selvey

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclósure

6

Indications for Use Statement

510(k) Number (if known):

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices

Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

| MANUFACTURER | MODEL
NUMBER | DESCRIPTION | |
|-------------------------------|-------------------------------|-------------------------------------|----------------------------------------|
| SMITH & NEPHEW RICHARDS, INC. | 100100 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100101 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100102 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100103 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100105 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100106 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100107 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100108 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100110 | ILIZAROV PART. THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100600 | ILIZAROV WIRE FIXATION BOLT SLOTTED | |
| SMITH & NEPHEW RICHARDS, INC. | 100700 | ILIZAROV WIRE FIXATION BOLT SLOTTED | |
| SMITH & NEPHEW RICHARDS, INC. | 100900 | ILIZAROV THREADED SOCKET | |
| SMITH & NEPHEW RICHARDS, INC. | 100901 | ILIZAROV SOCKET, THREADED | |
| SMITH & NEPHEW RICHARDS, INC. | 101302 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101307 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101309 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101351 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101352 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101355 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1357 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1358 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1359 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101402 | ILIZAROV SUPPORT MASCULINE END | |
| SMITH & NEPHEW RICHARDS, INC. | 101600 | ILIZAROV EXTERNAL FIXATION HINGE | |
| SMITH & NEPHEW RICHARDS, INC. | 101602 | ILIZAROV LOW PROFILE MALE HINGE | |
| 510(k) Number | SMITH & NEPHEW RICHARDS, INC. | 101800 | ILIZAROV SHORT CONNECTION PLATE 3-HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 101810 | ILIZAROV STRAIGHT BAR 2-HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 101900 | ILIZAROV TWISTED BAR 2-HOLE | |
| K012634 | SMITH & NEPHEW RICHARDS, INC. | 102300 | ILIZAROV ROD, THREADED |
| SMITH & NEPHEW RICHARDS, INC. | 103405 | ILIZAROV CENTERING SLEEVE | |
| SMITH & NEPHEW RICHARDS, INC. | 103406 | ILIZAROV SQUARE WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-345 | ILIZAROV EXTERNAL FIXATION DEVICE | |
| SMITH & NEPHEW RICHARDS, INC. | 103451 | ILIZAROV CUBE (1-HOLE) | |
| SMITH & NEPHEW RICHARDS, INC. | 201004 | ILIZAROV ARCH | |
| SMITH & NEPHEW RICHARDS, INC. | 201300 | ILIZAROV OBLIQUE SUPPORT CONNECTION | |
| SMITH & NEPHEW RICHARDS, INC. | 7110-1362 | ILIZAROV COMPOSITE RING | |
| SMITH & NEPHEW RICHARDS, INC. | 71033002 | EXTERNAL TIBIAL FIXATOR | |
| SMITH & NEPHEW RICHARDS, INC. | 71033006 | EXTERNAL TIBIAL FIXATOR | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0550 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0601 | WIRE FIXATION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0800 | BUSHING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1303 | HALF METAL RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1304 | METAL HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1306 | HALF METAL RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1353 | COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1356 | COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1500 | POST FEMALE END 2 HOLES | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1700 | HINGE FEMALE END | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1702 | HINGE FEMALE END | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1901 | TWIST PLATE 3 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2300 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2301 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2303 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2304 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2501 | HINGE 90 DEG. | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2706 | FIXATION BOLT WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2721 | SLOTTED WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3195 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3202 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3203 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3302 | 4PT. D/COUNTER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3310 | HEX NUT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3451 | CUBE 1 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3452 | CUBE 2 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3453 | CUBE 3 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 20-1700 | CONICAL WASHER COUPLE | |
| SMITH & NEPHEW RICHARDS, INC. | 7101-2005 | NYLON INSERT NUT | |

CONFIDENTIAL

sion Sign-Off)
ion of General, Restor
Icurological Devices

Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)

7

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

CONFIDENTIAL

2 Miller

Sion Sign-Off)
Lion of General, Restoration Restoration of General, Restoration of Genrological Devices

Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________