(36 days)
Not Found
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for anterior screw fixation to the cervical spine as an adjunct to fusion for multiple medical conditions, indicating a therapeutic purpose to treat disease.
No
Explanation: The device description and intended use clearly indicate that this is an implantable medical device (plate and screws) used for stabilization and fusion of the cervical spine, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (anterior plate, bone screws, locking screws, locking plate), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the SpineSmith Cequence Anterior Cervical Plate System is a physical implant used for anterior screw fixation to the cervical spine. It is a surgical device, not a device that analyzes biological samples.
- Intended Use: The intended use describes treating conditions like degenerative disc disease, spondylolisthesis, etc., through surgical implantation, not through laboratory testing of specimens.
The information provided describes a surgical implant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
- Degenerative disc disease [DDD] -- defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Spinal Stenosis .
- Tumors .
- Trauma (i.e. fracture) .
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
Mechanical test results demonstrate that the proposed Cequence System is substantially cquivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K082821
Page 1 of 2
SpineSmith Cequence Anterior Cervical Plate System
510(k) Summary of Safety and Effectivencss
| SUBMITTED BY | SpineSmith Partners, LP
8140 N. Mopac, Bldg II, Suite 120
Austin, TX 78759 | OCT 31 2008 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 3006404071 | |
| CONTACT PERSON | Robert Jones
Vice President, Research and Development
Phone: 512-206-0770
Fax: 512-637-6750
Email: rjones@spinesmithusa.com | |
| SUBMISSION PREPARED BY | Lisa Peterson
Kaedon Consulting, LLC
Phone: 512-507-0746 | |
| DATE PREPARED | September 22, 2008 | |
| CLASSIFICATION | KWQ 888.3060- Spinal Intervertebral Body Fixation
Orthosis | |
| COMMON NAME | Spinal Fixation System | |
| PROPRIETARY NAME | SpineSmith Cequence Anterior Cervical Plate System | |
| SUBSTANTIAL
EQUIVALENCE | The SpineSmith Cequence System was determined to be
substantially equivalent to the predicate device. | |
DEVICE DESCRIPTION
1 - - - - - - -
The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.
INDICATIONS:
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
1
K082821
Page 2 of 2
- . Degenerative disc disease [DDD] -- defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Spinal Stenosis .
- Tumors .
- Trauma (i.e. fracture) .
MECHANICAL TEST DATA
ﭘﺎ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔ ﺍﺱ ﮐﯽ ﻣ
Mechanical test results demonstrate that the proposed Cequence System is substantially cquivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. To the left of the eagle is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 2008
OCT 31 2008
% Mr. Robert Jones VP. Research and Development 8140 North Mopac, Building II, Suite 120 Austin, Texas 78759
Re: K082821
Spine Smith Partners, L.P.
Trade/Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 22, 2008 Received: September 25, 2008
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device 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 device complies 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.
3
Page 2 - Mr. Robert Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K082821
Page lot 1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SpineSmith Partners, LP Cequence Anterior Ccrvical Plate System
Indications for Use:
The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:
- Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis �
- Spinal Stenosis ●
- Tumors .
- . Trauma (i.e. fracture)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| -- | -------------------------------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K082821 |
|---|---|
| --------------- | --------- |