510(k) K020713

MS-30 LATERAL FEMORAL STEM by Sulzer Orthopedics, Inc. — Product Code LZO

K020713 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "MS-30 LATERAL FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on May 14, 2002. 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. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
March 5, 2002
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