Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
FDA premarket approval P850022/S031 · decided 2022-11-23
Approval details
- PMA number
- P850022
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2022-10-28
- Decision date
- 2022-11-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.
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