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510(k) K936037

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

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

Other clearances by Joint Medical Products Corp.

  • K955511 — ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP (February 26, 1996)
  • K954935 — S-ROM FEMORAL HIP STEM - SIZE 14 X 8 (January 22, 1996)
  • K944321 — S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II (August 14, 1995)
  • K951726 — S-ROM ZTP UHMWPE ACETABULAR CUP (June 21, 1995)
  • K951084 — S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS (May 31, 1995)
  • K951000 — ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM (April 14, 1995)
  • K941769 — KNEE PROTHESIS (February 1, 1995)
  • K934412 — COATED ZT PROXIMAL SLEEVE (June 3, 1994)
  • K931676 — S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG (May 18, 1994)
  • K935078 — S-ROM TOTAL HIP REPLACEMENT SYSTEM (March 9, 1994)

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