The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Zweymueller-sl Hip Prosthesis Stem.
| Device ID | K871453 |
| 510k Number | K871453 |
| Device Name: | ZWEYMUELLER-SL HIP PROSTHESIS STEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Contact | Sylvia K Pierpoint |
| Correspondent | Sylvia K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-07-13 |