The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Premier-total Hip.
| Device ID | K894051 |
| 510k Number | K894051 |
| Device Name: | PREMIER-TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| 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 | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024179097 | K894051 | 000 |
| 00889024179073 | K894051 | 000 |
| 00889024178991 | K894051 | 000 |
| 00889024178984 | K894051 | 000 |
| 00889024178656 | K894051 | 000 |
| 00889024178649 | K894051 | 000 |
| 00889024178489 | K894051 | 000 |
| 00889024178472 | K894051 | 000 |