K003848 is an FDA 510(k) clearance for the HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on January 11, 2001, 30 days after receiving the submission on December 12, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K003848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2000 |
| Decision Date | January 11, 2001 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC — Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |