The following data is part of a premarket notification filed by Scient'x with the FDA for Scient'x Cement Restrictor.
| Device ID | K052367 |
| 510k Number | K052367 |
| Device Name: | SCIENT'X CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SCIENT'X 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SCIENT'X 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-05 |
| Summary: | summary |