ARROWHEAD FIXATION DEVICE
FDA 510(k) clearance K100926 · decided 2010-10-29
Clearance details
- K-number
- K100926
- Device name
- ARROWHEAD FIXATION DEVICE
- Applicant
- Arrow Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-05
- Decision date
- 2010-10-29
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- HTY
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hampton, GA, US
- Third-party review
- No
- Expedited review
- No
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| OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750) | OSSIO , Ltd. | 2023-09-13 |
| Electro-Spec Steri-Caps (K231905) | Electro-Spec, Inc. | 2023-08-14 |
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Recalls involving this device
No recalls on record reference this clearance.