ADVANTAGE DRIVE SYSTEM
FDA 510(k) clearance K002523 · decided 2000-10-06
Clearance details
- K-number
- K002523
- Device name
- ADVANTAGE DRIVE SYSTEM
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-15
- Decision date
- 2000-10-06
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.