CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
FDA premarket approval P030034 · decided 2004-12-23
Approval details
- PMA number
- P030034
- Trade name
- CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2003-08-22
- Decision date
- 2004-12-23
- Days to decision
- 489 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM. THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM IS A NON-INVASIVE, PULSED ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.
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