The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom(tm) Total Lhip System W/ceramic Head.
| Device ID | K913231 |
| 510k Number | K913231 |
| Device Name: | S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Debra L Bing |
| Correspondent | Debra L Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295171485 | K913231 | 000 |
| 10603295171478 | K913231 | 000 |