510(k) K912713

S-ROM ZT HA PROXIMAL FEMORAL SLEEVE by Joint Medical Products Corp. — Product Code MEH

K912713 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "S-ROM ZT HA PROXIMAL FEMORAL SLEEVE". The FDA issued a decision of SN on December 30, 1991. 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. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 30, 1991
Date Received
June 20, 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