The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Ci Hip Instrumentation.
| Device ID | K071135 |
| 510k Number | K071135 |
| Device Name: | DEPUY CI HIP INSTRUMENTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2007-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295115281 | K071135 | 000 |