The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Moore Hip Prosthesis, Pmma Coated.
| Device ID | K811416 |
| 510k Number | K811416 |
| Device Name: | MOORE HIP PROSTHESIS, PMMA COATED |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-19 |
| Decision Date | 1981-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024165014 | K811416 | 000 |
| 00889024165007 | K811416 | 000 |