K161279 is an FDA 510(k) clearance for the Life Spine Metatarsal Hemi Implant. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on February 1, 2017, 271 days after receiving the submission on May 6, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K161279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2016 |
| Decision Date | February 01, 2017 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |