EBI OsteoGen Implantable Bone Growth Stimulators
FDA premarket approval P790005/S059 · decided 2018-03-30
Approval details
- PMA number
- P790005
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EBI OsteoGen Implantable Bone Growth Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2018-03-01
- Decision date
- 2018-03-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualification of an alternate-secondary, contract service provider to provide calibration, maintenance, and rental services of instrumentation and equipment used during qualification and validation activities for the EBI OsteoGen Implantable Gone Growth Stimulators, SpF Implantable Spinal Fusion Stimulators, Biomet EBI Bone Healing System, Biomet SpinalPak, and the Biomet OrthoPak.
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