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FDA 510(k)

SOFAMOR ORFIL SPINE FIXATION SYSTEM

K-Number: K934007 · 1994-06-02

ApplicantSofamor Co.
Decision Date1994-06-02
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOFAMOR ORFIL SPINE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Co.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K934007. 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 SOFAMOR ORFIL SPINE FIXATION SYSTEM?

SOFAMOR ORFIL SPINE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Sofamor Co.. The 510(k) number is K934007.

When did SOFAMOR ORFIL SPINE FIXATION SYSTEM receive FDA 510(k) clearance?

SOFAMOR ORFIL SPINE FIXATION SYSTEM received FDA 510(k) clearance on 1994-06-02, under 510(k) number K934007.

Who is the listed applicant for SOFAMOR ORFIL SPINE FIXATION SYSTEM?

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 SOFAMOR ORFIL SPINE FIXATION SYSTEM?

The FDA product code for SOFAMOR ORFIL SPINE FIXATION SYSTEM 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.

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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 FIXATIONK945022APOFIX CERVICAL SPINE FIXATIONK873977NEW 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

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

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