| K-number | K910193 |
| Device name | HUENE FIXATION SCREW |
| Applicant | Acu-Med, Inc. |
| Product code | HWC |
| Device class | Class II |
| Decision date | Aug 23, 1991 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 888.3040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov