C.S.M. Hip
FDA 510(k) K862752 · Protek, Inc.
510(k) numberK862752
Submission
- Device name
- C.S.M. Hip
- Applicant
- Protek, Inc.
Indianapolis, IN, US - Received
- July 22, 1986
- Decision date
- August 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Protek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893785 | ARC-2F Acetabular CupLWJ · Traditional | 08/09/1989SN |
| K893959 | P.S.A. Femoral Hip ProsthesisKWY · Traditional | 07/25/1989SE |
| K892059 | Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional | 07/19/1989SE |
| K883794 | Resubmitted CLW Acetabular Cup W/SulmeshLWJ · Traditional | 05/26/1989SE |
| K884952 | Various Femoral Hip Prostheses W/Self Lock CeramicLZO · Traditional | 05/10/1989SE |
| K884889 | Modified O.E.C. Univ. Self-Aligning Aceta. Comp.KWL · Traditional | 02/27/1989SE |
| K890054 | M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.JDI · Traditional | 02/08/1989SN |
| K884789 | New Jersey Femoral Hip Prosthesis for Cement AppliKWL · Traditional | 02/08/1989SN |
| K884888 | Modified New Jersey Acetabular Comp. & Bone ScrewsJDI · Traditional | 12/29/1988SN |
| K882671 | Samuelson Screwloc CupKWA · Traditional | 10/20/1988SE |
Questions and answers
When was C.S.M. Hip cleared by the FDA?
C.S.M. Hip (K862752) received a 510(k) decision of Substantially Equivalent on August 7, 1986, 16 days after the submission was received.