K813016 is an FDA 510(k) clearance for the ZEE TRACTION SPLINT. This device is classified as a Apparatus, Traction, Non-powered (Class I - General Controls, product code HST).
Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981, 28 days after receiving the submission on October 27, 1981.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K813016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1981 |
| Decision Date | November 24, 1981 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HST — Apparatus, Traction, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5850 |