TORQUE INSTRUMENT, MODEL 8500
FDA 510(k) clearance K001476 · decided 2000-08-04
Clearance details
- K-number
- K001476
- Device name
- TORQUE INSTRUMENT, MODEL 8500
- Applicant
- Spinalight, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-11
- Decision date
- 2000-08-04
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LXM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.