The following data is part of a premarket notification filed by Techmah Medical Llc with the FDA for Smartspace Shoulder System.
| Device ID | K191247 |
| 510k Number | K191247 |
| Device Name: | SmartSPACE Shoulder System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TechMah Medical LLC 2099 Thunderhead Rd., Suite 302 Knoxville, TN 37922 |
| Contact | Mohamed R. Mahfouz |
| Correspondent | Mary Vater Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-09 |
| Decision Date | 2019-11-15 |