510(k) K181761

Zimmer Biomet Select Ceramic Heads by Zimmer, Inc. — Product Code LZO

K181761 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer Biomet Select Ceramic Heads". The FDA issued a decision of Substantially Equivalent on Dec 26, 2018. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Zimmer, Inc. has 421 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 26, 2018
Date Received
Jul 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type
510(k)