The following data is part of a premarket notification filed by Tecres Spa with the FDA for Spacer-s.
| Device ID | K112983 |
| 510k Number | K112983 |
| Device Name: | SPACER-S |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-10-06 |
| Decision Date | 2011-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497000408 | K112983 | 000 |
| 28031497000392 | K112983 | 000 |