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FDA 510(k)

APOFIX CERVICAL SPINE FIXATION

K-Number: K945022 · 1995-05-15

ApplicantSofamor Co.
Decision Date1995-05-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

APOFIX CERVICAL SPINE FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Co.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K945022. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the APOFIX CERVICAL SPINE FIXATION?

APOFIX CERVICAL SPINE FIXATION is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Sofamor Co.. The 510(k) number is K945022.

When did APOFIX CERVICAL SPINE FIXATION receive FDA 510(k) clearance?

APOFIX CERVICAL SPINE FIXATION received FDA 510(k) clearance on 1995-05-15, under 510(k) number K945022.

Who is the listed applicant for APOFIX CERVICAL SPINE FIXATION?

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

What is the FDA product code for APOFIX CERVICAL SPINE FIXATION?

The FDA product code for APOFIX CERVICAL SPINE FIXATION is KWP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sofamor Co. 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.

K940744SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATIONK934007SOFAMOR ORFIL SPINE FIXATION SYSTEMK873977NEW C-D SYSTEM FOR SPINAL SURGERYK843687ROD FOR RACHIS SURGERY

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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