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FDA 510(k)

LINK SADDLE PROTHESIS

K-Number: K951355 · 1995-05-25

ApplicantTurnkey Intergration USA, Inc.
Decision Date1995-05-25
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK SADDLE PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1995-05-25 under 510(k) number K951355. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK SADDLE PROTHESIS?

LINK SADDLE PROTHESIS is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K951355.

When did LINK SADDLE PROTHESIS receive FDA 510(k) clearance?

LINK SADDLE PROTHESIS received FDA 510(k) clearance on 1995-05-25, under 510(k) number K951355.

Who is the listed applicant for LINK SADDLE PROTHESIS?

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

What is the FDA product code for LINK SADDLE PROTHESIS?

The FDA product code for LINK SADDLE PROTHESIS is KWL.

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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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