The following data is part of a premarket notification filed by Tecres Spa with the FDA for Spacer-s Temporary Shoulder Spacer.
| Device ID | K060535 |
| 510k Number | K060535 |
| Device Name: | SPACER-S TEMPORARY SHOULDER SPACER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | TECRES SPA 2320 N.W. 66TH COURT Gainsville, FL 32653 |
| Contact | Diane Taylor |
| Correspondent | Diane Taylor TECRES SPA 2320 N.W. 66TH COURT Gainsville, FL 32653 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-05-24 |
| Summary: | summary |