LDR SPINE EASYSPINE SYSTEM
FDA 510(k) clearance K082592 · decided 2008-10-08
Clearance details
- K-number
- K082592
- Device name
- LDR SPINE EASYSPINE SYSTEM
- Applicant
- Ldr Spine USA
- Decision
- Substantially Equivalent
- Date received
- 2008-09-08
- Decision date
- 2008-10-08
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.