The following data is part of a premarket notification filed by Theken Surgical,llc with the FDA for Theken Large Cement Restrictor.
| Device ID | K012462 |
| 510k Number | K012462 |
| Device Name: | THEKEN LARGE CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | THEKEN SURGICAL,LLC 1100 NOLA AVE. Barbeton, OH 44203 -3819 |
| Contact | Randy Theken |
| Correspondent | Randy Theken THEKEN SURGICAL,LLC 1100 NOLA AVE. Barbeton, OH 44203 -3819 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2001-10-29 |
| Summary: | summary |