LINK ENDO MODEL REVISION CUP

Plate, Fixation, Bone

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Endo Model Revision Cup.

Pre-market Notification Details

• Device ID: K943986
• 510k Number: K943986
• Device Name: LINK ENDO MODEL REVISION CUP
• Classification: Plate, Fixation, Bone
• Applicant: TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290
• Contact: Douglas W Stuart
• Correspondent: Douglas W Stuart; TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-16
• Decision Date: 1995-07-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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04026575048496	K943986	000
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