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510(k) K951000

ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM by Joint Medical Products Corp. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1995
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
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)
  • K941769 — KNEE PROTHESIS (February 1, 1995)
  • K936037 — S-ROM NOILES CRUCIATE RETAINING KNEE (October 3, 1994)
  • 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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