The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Hip Sys W/cal-coated Can Str Titanium (csti).
| Device ID | K954800 |
| 510k Number | K954800 |
| Device Name: | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Barry J Hassett |
| Correspondent | Barry J Hassett INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024174221 | K954800 | 000 |
| 00889024166790 | K954800 | 000 |
| 00889024166783 | K954800 | 000 |
| 00889024166776 | K954800 | 000 |
| 00889024166561 | K954800 | 000 |
| 00889024166554 | K954800 | 000 |
| 00889024166547 | K954800 | 000 |
| 00889024166332 | K954800 | 000 |
| 00889024166325 | K954800 | 000 |
| 00889024166318 | K954800 | 000 |
| 00889024644014 | K954800 | 000 |
| 00889024174108 | K954800 | 000 |
| 00889024174115 | K954800 | 000 |
| 00889024174214 | K954800 | 000 |
| 00889024174207 | K954800 | 000 |
| 00889024174191 | K954800 | 000 |
| 00889024174184 | K954800 | 000 |
| 00889024174177 | K954800 | 000 |
| 00889024174160 | K954800 | 000 |
| 00889024174153 | K954800 | 000 |
| 00889024174146 | K954800 | 000 |
| 00889024174139 | K954800 | 000 |
| 00889024174122 | K954800 | 000 |
| 00889024643741 | K954800 | 000 |