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 |