ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
FDA 510(k) clearance K141509 · decided 2014-08-22
Clearance details
- K-number
- K141509
- Device name
- ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
- Applicant
- Medos Sarl
- Decision
- Substantially Equivalent
- Date received
- 2014-06-06
- Decision date
- 2014-08-22
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- PGM
- 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.