The following data is part of a premarket notification filed by Orthopaedic Device Corp. with the FDA for P.t.h. Metal-backed Acetabular Cup.
| Device ID | K870234 |
| 510k Number | K870234 |
| Device Name: | P.T.H. METAL-BACKED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | ORTHOPAEDIC DEVICE CORP. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Alex Khowaylo |
| Correspondent | Alex Khowaylo ORTHOPAEDIC DEVICE CORP. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-03-20 |