K071173 is an FDA 510(k) clearance for the RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D. This device is classified as a Tong, Skull For Traction (Class II - Special Controls, product code HAX).
Submitted by Ossur Americans (Formerly the Jerome Group) (Paulsboro, US). The FDA issued a Cleared decision on May 25, 2007, 28 days after receiving the submission on April 27, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5960.
| 510(k) Number | K071173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2007 |
| Decision Date | May 25, 2007 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAX — Tong, Skull For Traction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5960 |