K102885 is an FDA 510(k) clearance for the HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Stryker Corp. (Mahwah, US). The FDA issued a Cleared decision on January 14, 2011, 106 days after receiving the submission on September 30, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K102885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2010 |
| Decision Date | January 14, 2011 |
| Days to Decision | 106 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 |