Link Endo Model Revision Cup
FDA 510(k) K943986 · Turnkey Intergration USA, Inc.
510(k) numberK943986
Submission
- Device name
- Link Endo Model Revision Cup
- Applicant
- Turnkey Intergration USA, Inc.
Indianapolis, IN, US - Received
- August 16, 1994
- Decision date
- July 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
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| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K991405 | Omni-Fix, Humeral NailKTW · Traditional | 06/29/1999SE |
| K990523 | B2C, Espace Revision Cup SystemLPH · Traditional | 04/30/1999SE |
| K990307 | Omni-Fix, Nail SystemKTW · Traditional | 04/01/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | 08/29/1997SE |
| K970284 | Artos, Diplos SystemKWY · Traditional | 04/21/1997SE |
| K970084 | Link Cerclage Wire SystemJDQ · Traditional | 03/13/1997SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | 11/06/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
| K950397 | System 22 ValveBYE · Traditional | 04/14/1995SE |
| K940297 | Universal WristJWI · Traditional | 02/06/1995SN |
Questions and answers
When was Link Endo Model Revision Cup cleared by the FDA?
Link Endo Model Revision Cup (K943986) received a 510(k) decision of Substantially Equivalent on July 5, 1995, 323 days after the submission was received.
What is the product code of K943986?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.