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FDA 510(k)

EDWARDS SACRAL SCREW

K-Number: K851935 · 1985-06-07

ApplicantZimmer, Inc.
Decision Date1985-06-07
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDWARDS SACRAL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1985-06-07 under 510(k) number K851935. 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 EDWARDS SACRAL SCREW?

EDWARDS SACRAL SCREW is a medical device that received FDA 510(k) clearance on 1985-06-07. The listed applicant is Zimmer, Inc.. The 510(k) number is K851935.

When did EDWARDS SACRAL SCREW receive FDA 510(k) clearance?

EDWARDS SACRAL SCREW received FDA 510(k) clearance on 1985-06-07, under 510(k) number K851935.

Who is the listed applicant for EDWARDS SACRAL SCREW?

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

What is the FDA product code for EDWARDS SACRAL SCREW?

The FDA product code for EDWARDS SACRAL SCREW is KWP.

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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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