(50 days)
Not Found
No
The 510(k) summary describes a mechanical implant system (plates, screws, etc.) and does not mention any software, image processing, or AI/ML terms.
Yes
The device is intended for anterior cervical fixation for various medical conditions like degenerative disc disease, spondylolisthesis, and trauma, which aligns with the definition of a therapeutic device.
No
The C-Plate™ Anterior Cervical Plate System is described as a system for anterior cervical fixation to treat various conditions, not to diagnose them. It consists of plates, screws, and instruments, which are used in a therapeutic or surgical capacity, not for diagnostic assessment.
No
The device description explicitly states it consists of physical components like plates, screws, sub-plates, rivets, and instruments, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for anterior cervical fixation to treat various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The description lists components like plates, screws, and instruments, which are typical of surgical implants and tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to stabilize the spine.
N/A
Intended Use / Indications for Use
The C-Plate™ Anterior Cervical Plate System is intended for anterior cervical fixation for 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, .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- . tumor,
- · . pseudoarthrosis,
- failed previous fusion. .
Product codes
KWQ
Device Description
The C-Plate Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and associated instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
A section outlining the technological characteristics and specific performance tests is not applicable for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MAXIMA™ Anterior Cervical Plate System (K061002)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ﻤﺴﺎ ﺳ
510(k) Summary
SEP 2 9 2010
LDR Spine C-Plate™ Anterior Cervical Plate System
1. Owner's Name & Address
LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: (512) 344-3333 (512) 344-3350 Fax:
2. Contact Person
Beckinam Nowatzke, MSRS
Quality Engineering and Regulatory Affairs Project Manager LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: (512) 344-3407 Fax: (512) 344-3350 Email: beckinowatzke@Idrspine.com
3. Date 510(k) Summary Prepared: September 2, 2010
LDR Spine C-Plate™ Anterior Cervical Plate System 4. Trade Name: Common Name: Anterior Cervical Plate System (KWQ) KWQ (per 21 CFR 888.3060) - Spinal intervertebral body Classification: fixation orthosis
5. Legally Marketed Equivalent Predicate Device: MAXIMA™ Anterior Cervical Plate System (K061002)
6. Device Description
The C-Plate Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and associated instruments.
7. Intended Use of the Device
The C-Plate™ Anterior Cervical Plate System is intended for anterior cervical fixation for 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, .
1
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- . tumor,
- · . pseudoarthrosis,
- failed previous fusion. .
A section outlining the technological characteristics and specific performance tests is not applicable for this submission.
The proposed LDR Spine C-Plate™ Anterior Cervical Plate System is exactly the same as the predicate MAXIMA™ Anterior Cervical Plate System (cleared via K061002) and the purpose of this submission is to transfer the ownership and name of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LDR Spine USA % Beckinam Nowatzke, MSRS Quality Engineering and Regulatory Affairs Project Manager 4030 West Braker Lane, Suite 360 Austin, Texas 78759
SEP 2 9 2010
Re: K102265
Trade/Device Name: C-Plate™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 02, 2010 Received: September 03, 2010
Dear Ms. Nowatzke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Beckinam Nowatzke, MSRS
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Millerson
Mark N: Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K102265
SEP 29 2010
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
LDR Spine USA C-Plate™ Anterior Cervical Plate System
Indications for Use:
The C-Plate™ Anterior Cervical Plate System is intended for anterior cervical fixation for 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
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- · Tumor
- · Pseudoarthrosis
- Failed previous fusion
Prescription Use × (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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K102265 510(k) Number_