K901456 is an FDA 510(k) clearance for the ORTHOSORB(R) ABSORBABLE PIN. This device is classified as a Pin, Fixation, Resorbable, Hard Tissue (Class II - Special Controls, product code OVZ).
Submitted by Johnson & Johnson International (Braintree, US). The FDA issued a Cleared decision on August 15, 1990, 141 days after receiving the submission on March 27, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications..
| 510(k) Number | K901456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1990 |
| Decision Date | August 15, 1990 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | OVZ — Pin, Fixation, Resorbable, Hard Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications. |