Link Saddle Prothesis
FDA 510(k) K943277 · Turnkey Intergration USA, Inc.
510(k) numberK943277
Submission
- Device name
- Link Saddle Prothesis
- Applicant
- Turnkey Intergration USA, Inc.
Indianapolis, IN, US - Received
- July 7, 1994
- Decision date
- January 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Turnkey Intergration USA, Inc.
| 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 |
| K943986 | Link Endo Model Revision CupHRS · Traditional | 07/05/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
| K950397 | System 22 ValveBYE · Traditional | 04/14/1995SE |
Questions and answers
When was Link Saddle Prothesis cleared by the FDA?
Link Saddle Prothesis (K943277) received a 510(k) decision of Substantially Equivalent on January 26, 1995, 203 days after the submission was received.