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FDA 510(k)

SYNTHES SPINE CERVIFIX SYSTEM

K-Number: K984377 · 1999-01-21

ApplicantSynthes (Usa)
Decision Date1999-01-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SPINE CERVIFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1999-01-21 under 510(k) number K984377. 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 SYNTHES SPINE CERVIFIX SYSTEM?

SYNTHES SPINE CERVIFIX SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-21. The listed applicant is Synthes (Usa). The 510(k) number is K984377.

When did SYNTHES SPINE CERVIFIX SYSTEM receive FDA 510(k) clearance?

SYNTHES SPINE CERVIFIX SYSTEM received FDA 510(k) clearance on 1999-01-21, under 510(k) number K984377.

Who is the listed applicant for SYNTHES SPINE CERVIFIX SYSTEM?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES SPINE CERVIFIX SYSTEM?

The FDA product code for SYNTHES SPINE CERVIFIX SYSTEM is KWP.

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Other records listing Synthes (Usa) as applicant

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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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