The following data is part of a premarket notification filed by Tecres Spa with the FDA for Spacer-k Temporary Knee Spacer With Gentamicin, Models Spk0021, Spk0121, Spk0221, Spk0321.
| Device ID | K062274 |
| 510k Number | K062274 |
| Device Name: | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TECRES SPA 2320 N.W. 66TH COURT Gainesville, FL 32653 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor TECRES SPA 2320 N.W. 66TH COURT Gainesville, FL 32653 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| 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 |