BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
FDA premarket approval P850022/S020 · decided 2013-09-12
Approval details
- PMA number
- P850022
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Trade name
- BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2013-08-13
- Decision date
- 2013-09-12
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR IMPLEMENTING A COMPLIMENTARY QUALITY CONTROL PROCEDURE.
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