K800143 is an FDA 510(k) clearance for the DYNAMIC EXTENSOR SPLINT. This device is classified as a Splint, Hand, And Components (Class I - General Controls, product code ILH).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1980, 29 days after receiving the submission on January 21, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K800143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1980 |
| Decision Date | February 19, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILH — Splint, Hand, And Components |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |