MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k) clearance K070901 · decided 2007-06-15
Clearance details
- K-number
- K070901
- Device name
- MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- Applicant
- Bioplate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-02
- Decision date
- 2007-06-15
- Days to decision
- 74 days
- Clearance type
- Special
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.