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FDA 510(k)

FS 1000 KNEE SYSTEM

K-Number: K991052 · 1999-11-10

ApplicantRenaissance Instruments, LLC
Decision Date1999-11-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FS 1000 KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Renaissance Instruments, LLC. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K991052. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FS 1000 KNEE SYSTEM?

FS 1000 KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Renaissance Instruments, LLC. The 510(k) number is K991052.

When did FS 1000 KNEE SYSTEM receive FDA 510(k) clearance?

FS 1000 KNEE SYSTEM received FDA 510(k) clearance on 1999-11-10, under 510(k) number K991052.

Who is the listed applicant for FS 1000 KNEE SYSTEM?

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

What is the FDA product code for FS 1000 KNEE SYSTEM?

The FDA product code for FS 1000 KNEE SYSTEM is JWH.

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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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