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 |