Screw, Oral
FDA product code KBW · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
1510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K936050 | Jaw SpreaderKBW · Traditional | Gam Industries, Inc. | 03/24/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2779-2011 | Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT…Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5… | Biomet Microfixation, Inc. | 06/25/2010Terminated |