510(k) K915617

LSF HA COATED FEMORAL HIP by Implant Technology, Inc. — Product Code MEH

K915617 is an FDA 510(k) premarket notification submitted by Implant Technology, Inc. for the device "LSF HA COATED FEMORAL HIP". The FDA issued a decision of Substantially Equivalent on May 28, 1992. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Implant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
December 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type