The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Premier-total (tm) Hip.
| Device ID | K873999 |
| 510k Number | K873999 |
| Device Name: | PREMIER-TOTAL (TM) HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-01 |
| Decision Date | 1987-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024174542 | K873999 | 000 |
| 00889024174467 | K873999 | 000 |
| 00889024174474 | K873999 | 000 |
| 00889024174481 | K873999 | 000 |
| 00889024174498 | K873999 | 000 |
| 00889024174504 | K873999 | 000 |
| 00889024174511 | K873999 | 000 |
| 00889024174528 | K873999 | 000 |
| 00889024174535 | K873999 | 000 |
| 00889024174450 | K873999 | 000 |