510(k) K944321
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