The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Acetabular Cup(part Of S-rom 135tm Total Hip.
| Device ID | K851421 |
| 510k Number | K851421 |
| Device Name: | S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Douglas G Noiles |
| Correspondent | Douglas G Noiles JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-06-04 |