Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
FDA premarket approval P060037/S050 · decided 2017-09-29
Approval details
- PMA number
- P060037
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2017-08-31
- Decision date
- 2017-09-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- New and modified heat seal parameters, which define the process parameters for the heat sealing of sterile package lidding to thermoformed polymer trays as part of the packaging configuration for NexGen LPS-Flex/LPS-Mobile Bearing Knee System tibial bearing components.
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