The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Peek Cement Restrictor X-box.
| Device ID | K041583 |
| 510k Number | K041583 |
| Device Name: | PEEK CEMENT RESTRICTOR X-BOX |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | INNOVASIS, INC. 997 EAST 3900 SOUTH SUITE 103 Salt Lake City, UT 84124 |
| Contact | Brent A Felix |
| Correspondent | Brent A Felix INNOVASIS, INC. 997 EAST 3900 SOUTH SUITE 103 Salt Lake City, UT 84124 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-11 |
| Decision Date | 2004-07-22 |
| Summary: | summary |