510(k) K183457
K183457 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head". The FDA issued a decision of Substantially Equivalent on Nov 5, 2019. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Zimmer, Inc. has 421 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2019
- Date Received
- Dec 13, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type
- 510(k)