K071064 is an FDA 510(k) clearance for the ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 22, 2007, 67 days after receiving the submission on April 16, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K071064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2007 |
| Decision Date | June 22, 2007 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3690 |