← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K083338 # CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (K083338) _Seaspine, Inc. · KWQ · Feb 2, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K083338 ## Device Facts - **Applicant:** Seaspine, Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Feb 2, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, trauma (including fracture or dislocation), spinal stenosis, cervical myelopathy, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. ## Device Story Cardiff™ Anterior Cervical Plate (ACP) System is a spinal intervertebral body fixation orthosis; consists of bone plates, screws, and associated instruments. Implants manufactured from Titanium 6AL-4V ELI and Nitinol SE508. Used by surgeons in clinical settings for anterior interbody screw fixation of cervical spine. Fixation achieved via bone screws inserted into vertebral body during anterior approach. Provides temporary stabilization to facilitate spinal fusion. Benefits include structural support during bone healing process. ## Clinical Evidence Bench testing only; no clinical data required. ## Technological Characteristics Materials: Titanium 6AL-4V ELI and Nitinol SE508. Components: Bone plates, screws, and associated instruments. Fixation: Anterior interbody screw fixation. Form factor: Anterior cervical plate system for C2-C7 stabilization. ## Regulatory 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. ## Predicate Devices - SeaSpine Sonoma™ Anterior Cervical Plate System ([K032368](/device/K032368.md)) - Blackstone™ Anterior Cervical Plate system ([K974885](/device/K974885.md)) - Medtronic Sofamor Danek Zephir™ system ([K994239](/device/K994239.md)) - Synthes CSLP System ([K926453](/device/K926453.md), [K945700](/device/K945700.md), [K000536](/device/K000536.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Cardiff™ Premarket Notification ## 510(k) Summary Company Name: SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081 Contact Person: Ethel Bernal Regulatory Affairs Manager E-mail: ebernal@seaspine.com Phone: (760) 727-8399 x218, Fax: (760) 727-8809 Date Prepared: November 10, 2008 Trade Name: Cardiff™ Common Name: Classification Name: Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060, Product Code: KWQ, Class II Orthopedic Review Committee Device Description: The Cardiff™ Anterior Cervical Plate (ACP) System is intended for anterior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, Cardiff™ ACP System implants are and associated instruments. manufactured from Titanium 6AL-4V ELI and Nitinol SE508. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. This system is indicated for use in the temporary stabilization of the Intended Use: anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: > degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, trauma (including fracture or dislocation), spinal stenosis, cervical myelopathy, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. Substantial Equivalence: Cardiff™ was shown to be substantially equivalent in whole or in part to the following commercially available predicate device(s): - SeaSpine Sonoma™ Anterior Cervical Plate System (510(k) . number K032368) K083338 EB = 2 2009 {1}------------------------------------------------ Cardiff™ Premarket Notification - . Blackstone™ Anterior Cervical Plate system (510(k) number K974885) - Medtronic Sofamor Danek Zephir™ system (510 (k) number . K994239) - Synthes CSLP System (510(k) numbers K926453, K945700 and . K000536) Performance Data: Mechanical testing results indicated that Cardiff™ possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s). Clinical data was not required for this device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, clutching a staff entwined with a snake, which is a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service FEB -2 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SeaSpine Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, California 92081-7862 Re: K083338 Trade/Device Name: Cardiff™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Anterior cervical system Regulatory Class: II Product Code: KWQ Dated: November 10, 2008 Received: November 13, 2008 Dear Ms. Bernal: 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 includions for use stated in the enclosure) to legally marketed predicate devices market in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Americanse 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, noand 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 more 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 mater not not not hite 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 100-1050. {3}------------------------------------------------ ## Page 2- Ms. Ethel Bernal 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 Biometrics' (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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html, Sincerely yours. Mark N Mulkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Cardiff™ Premarket Notification ### Indications for Use 510(k) Number (if known): Device Name: Cardiff™ Anterior Cervical Plate System Indications for Use: This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: - degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies, - trauma (including fracture or dislocation), - spinal stenosis, - cervical myelopathy, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - tumor, - pseudoarthrosis, and/or - failed previous fusion. Prescription Use __ × (Part 21 CFR 801 Subpart D). AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) f (Division Sign Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K083338](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K083338) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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