The following data is part of a premarket notification filed by Tecres Spa with the FDA for Spacer-k, Spacer-g, Spacer-s.
| Device ID | K101356 |
| 510k Number | K101356 |
| Device Name: | SPACER-K, SPACER-G, SPACER-S |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TECRES SPA 7 Trail House Court Rockville, MD 20850 |
| Contact | Christine Brauer |
| Correspondent | Christine Brauer TECRES SPA 7 Trail House Court Rockville, MD 20850 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-05-14 |
| Decision Date | 2011-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497001160 | K101356 | 000 |
| 28031497000590 | K101356 | 000 |
| 28031497000606 | K101356 | 000 |
| 28031497000613 | K101356 | 000 |
| 28031497000620 | K101356 | 000 |
| 28031497000637 | K101356 | 000 |
| 28031497000644 | K101356 | 000 |
| 28031497000651 | K101356 | 000 |
| 28031497000668 | K101356 | 000 |
| 28031497000583 | K101356 | 000 |