K001507 is an FDA 510(k) clearance for the MICROPERFORATION INSTRUMENT. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 14, 2000, 30 days after receiving the submission on May 15, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K001507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2000 |
| Decision Date | June 14, 2000 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |