The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Premier-total(tm) Hip With Calcitite(r) Coating.
Device ID | K910755 |
510k Number | K910755 |
Device Name: | PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
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 | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-15 |
Decision Date | 1991-03-26 |