The following data is part of a premarket notification filed by Tecres Spa with the FDA for Spacer-g Temporary Hip Prosthesis.
| Device ID | K062273 |
| 510k Number | K062273 |
| Device Name: | SPACER-G TEMPORARY HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | TECRES SPA 2320 N.W. 66TH COURT Gainesville, FL 32653 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor TECRES SPA 2320 N.W. 66TH COURT Gainesville, FL 32653 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-08-07 |
| Decision Date | 2008-05-22 |
| Summary: | summary |