510(k) K936037

S-ROM NOILES CRUCIATE RETAINING KNEE by Joint Medical Products Corp. — Product Code JWH

K936037 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "S-ROM NOILES CRUCIATE RETAINING KNEE". The FDA issued a decision of SN on October 3, 1994. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 3, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type