The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apollo(tm) Hip Syst-straight Stem/all-poly Acet Comp.
Device ID | K933203 |
510k Number | K933203 |
Device Name: | APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
Contact | Joann Ringer |
Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-01 |
Decision Date | 1994-04-19 |