510(k) K944321

S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II by Joint Medical Products Corp. — Product Code JWH

K944321 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II". The FDA issued a decision of SN on August 14, 1995. 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
August 14, 1995
Date Received
September 2, 1994
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