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FDA 510(k)

REVO ROTATOR CUFF REPAIR SYSTEM

K-Number: K941691 · 1994-09-06

ApplicantLinvatec Corp.
Decision Date1994-09-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVO ROTATOR CUFF REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K941691. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVO ROTATOR CUFF REPAIR SYSTEM?

REVO ROTATOR CUFF REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Linvatec Corp.. The 510(k) number is K941691.

When did REVO ROTATOR CUFF REPAIR SYSTEM receive FDA 510(k) clearance?

REVO ROTATOR CUFF REPAIR SYSTEM received FDA 510(k) clearance on 1994-09-06, under 510(k) number K941691.

Who is the listed applicant for REVO ROTATOR CUFF REPAIR SYSTEM?

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

What is the FDA product code for REVO ROTATOR CUFF REPAIR SYSTEM?

The FDA product code for REVO ROTATOR CUFF REPAIR SYSTEM is HRX.

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Related Devices (Code: HRX)

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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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