K101356 is an FDA 510(k) clearance for the Spacer-G and Spacer-K. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on September 20, 2011, 494 days after receiving the submission on May 14, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K101356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2010 |
| Decision Date | September 20, 2011 |
| Days to Decision | 494 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL - Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |