| K-number | K944756 |
| Device name | ISOLA OPEN AND CLOSED SCREWS |
| Applicant | Acromed Corp. |
| Product code | MNH |
| Device class | Class II |
| Decision date | May 30, 1995 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 888.3070 |
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