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FDA 510(k)

VERSALOK SCREW ASSEMBLY (PROPOSED NAME)

K-Number: K961572 · 1996-09-17

ApplicantWrightmedicaltechnologyinc
Decision Date1996-09-17
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

VERSALOK SCREW ASSEMBLY (PROPOSED NAME) is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1996-09-17 under 510(k) number K961572. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the VERSALOK SCREW ASSEMBLY (PROPOSED NAME)?

VERSALOK SCREW ASSEMBLY (PROPOSED NAME) is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K961572.

When did VERSALOK SCREW ASSEMBLY (PROPOSED NAME) receive FDA 510(k) clearance?

VERSALOK SCREW ASSEMBLY (PROPOSED NAME) received FDA 510(k) clearance on 1996-09-17, under 510(k) number K961572.

Who is the listed applicant for VERSALOK SCREW ASSEMBLY (PROPOSED NAME)?

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

What is the FDA product code for VERSALOK SCREW ASSEMBLY (PROPOSED NAME)?

The FDA product code for VERSALOK SCREW ASSEMBLY (PROPOSED NAME) is MNH. This falls under the ENT category.

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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