The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Ii Non Porous Hip Stem.
Device ID | K944209 |
510k Number | K944209 |
Device Name: | APR II NON POROUS HIP STEM |
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 | Barry J Hassett |
Correspondent | Barry J Hassett 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 | 1994-08-29 |
Decision Date | 1994-12-09 |