Link Cerclage Wire System
FDA 510(k) K970084 · Turnkey Intergration USA, Inc.
510(k) numberK970084
Submission
- Device name
- Link Cerclage Wire System
- Applicant
- Turnkey Intergration USA, Inc.
Sarasota, FL, US - Received
- January 9, 1997
- Decision date
- March 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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| K970284 | Artos, Diplos SystemKWY · Traditional | 04/21/1997SE |
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| K943986 | Link Endo Model Revision CupHRS · Traditional | 07/05/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
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| K940297 | Universal WristJWI · Traditional | 02/06/1995SN |
Questions and answers
When was Link Cerclage Wire System cleared by the FDA?
Link Cerclage Wire System (K970084) received a 510(k) decision of Substantially Equivalent on March 13, 1997, 63 days after the submission was received.
What is the product code of K970084?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.