The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Femoral Hip Stem - Size 14 X 8.
| Device ID | K954935 |
| 510k Number | K954935 |
| Device Name: | S-ROM FEMORAL HIP STEM - SIZE 14 X 8 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Amy Walters |
| Correspondent | Amy Walters 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 | 1995-10-27 |
| Decision Date | 1996-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295178200 | K954935 | 000 |
| 10603295170945 | K954935 | 000 |