MAYFIELD SKULL CLAMP
FDA 510(k) clearance K120633 · decided 2012-05-24
Clearance details
- K-number
- K120633
- Device name
- MAYFIELD SKULL CLAMP
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-03-01
- Decision date
- 2012-05-24
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cr recall (Z-0210-2014) | Integra LifeSciences Corp. | 2013-11-13 |
| MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull C recall (Z-0559-2013) | Integra LifeSciences Corporation | 2012-12-19 |