Bionx Implants, Inc. · Class II · Cleared May 25, 2001
| K-number | K010554 |
| Device name | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A |
| Applicant | Bionx Implants, Inc. |
| Product code | HWC |
| Device class | Class II |
| Decision date | May 25, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
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