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FDA 510(k)

OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM

K-Number: K021009 · 2002-06-18

ApplicantSpinal Concepts, Inc.
Decision Date2002-06-18
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2002-06-18 under 510(k) number K021009. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM?

OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-18. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K021009.

When did OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM receive FDA 510(k) clearance?

OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM received FDA 510(k) clearance on 2002-06-18, under 510(k) number K021009.

Who is the listed applicant for OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM?

The FDA 510(k) record lists Spinal Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM?

The FDA product code for OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM is KWP.

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Other records listing Spinal Concepts, Inc. as applicant

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K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK050706HARMONY PORT SYSTEM, MODEL 1907 SERIESK040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMK033663SPINAL CONCEPTS INC. CODAK033517SPINAL CONCEPTS INC. CADENCE AND TRAXISK031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

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Related Devices (Code: KWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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