510(k) K955296

LINK MP RECONSTRUCTION HIP by Link America, Inc. — Product Code JDI

K955296 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "LINK MP RECONSTRUCTION HIP". The FDA issued a decision of Substantially Equivalent on February 14, 1996. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Link America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1996
Date Received
November 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type