(90 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is an internal fixation device intended for stabilization of the cervical spine to enhance the development of a solid fusion. While it helps stabilize the spine, its primary role is structural support and fixation, rather than direct therapeutic treatment in the sense of delivering a substance, energy, or modulating a physiological process for a therapeutic effect. It facilitates healing, but it is a mechanical support, not a therapeutic agent.
No
The device is described as an "internal fixation device" intended for "correction and stabilization of the cervical spine" and to "enhance the development of a solid fusion." Its purpose is to physically support and stabilize the spine, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a titanium alloy anterior cervical plate fixation system consisting of plates, screws, and cover plates, which are physical hardware components.
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 C3™ Anterior Cervical Plate System is a physical implantable device (a plate and screws) used for surgical fixation and stabilization of the cervical spine. It is used in vivo (within the body) during surgery, not in vitro (in a lab setting) on samples.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activity typically associated with IVDs.
This device is a surgical implant used for structural support and stabilization of the spine.
N/A
Intended Use / Indications for Use
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Product codes
KWQ
Device Description
The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to 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)
Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
C3" Anterior Cervical Plate System
510 (k) Summary
SpineVision, Inc. Company: 3003 Summit Blvd., Suite 1500 Atlanta, GA 30319
NOV 2 6 2001
C3™ Anterior Cervical Plate System Trade Name:
Classification: KWQ 888.3060. Spinal Intervertebral Body Fixation Orthosis. Class II.
The C3 ... Anterior Cervical Plate System is a titanium alloy anterior cervical plate Description: The system consists of a number of plates and screws of fixation system. varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
Performance Data:
Non-clinical:
Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.
Intended Use:
The Carn Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The Call Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Substantial Equivalence:
Synthes (USA) Synthes Spine Anterior CSLP (K000742)
Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2001
David W. Mullis, Jr., Ph.D., RAC Consultant for Spine Vision, Inc. Mullis & Associates, Inc .. Box 39 367 Pleasant Valley Road Good Hope, Georgia 30641
Re: K012881
Trade/Device Name: C3™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 27, 2001 Received: August 28, 2001
Dear Dr. Mullis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - David W. Mullis, Jr., Ph.D., RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 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 your device, (Jaase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Walker, us
Image /page/2/Picture/5 description: The image contains what appears to be a signature. The signature is written in cursive and is illegible. The signature is in black ink and is on a white background.
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
Enclosure --
3
510(k) Number: K012881
Device Name: C3™ Anterior Cervical Plate System
Intended Use:
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-1-96)
Susan Walker
Division Sign-Off Division of General. Restorative and Neurological Devices
510(k) Number K012881