EXPEDIUM SPINE SYSTEM
FDA 510(k) clearance K110551 · decided 2011-10-26
Clearance details
- K-number
- K110551
- Device name
- EXPEDIUM SPINE SYSTEM
- Applicant
- Johnson & Johnson
- Decision
- Substantially Equivalent
- Date received
- 2011-02-28
- Decision date
- 2011-10-26
- Days to decision
- 240 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.