S-Rom Total Hip Replacement System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935078 ↗

FDA Product Code

JDG

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SN

• S-ROM Total Hip Replacement System

  Class II

  FDA 510(k) K920739 Active Cleared 24 Nov 1992

• S-ROM ZTT Acetabular Cup-Apical Hole Plug

  Class III

  FDA 510(k) K931676 Active Cleared 18 May 1994

• S-Rom Femoral Hip Stem - Size 14 X 8

  Class II

  FDA 510(k) K954935 Active Cleared 22 Jan 1996

• Knee Prothesis

  Class II

  FDA 510(k) K941769 Active Cleared 1 Feb 1995

• Src Total Knee

  Not classified

  FDA 510(k) K841022 Active Cleared 25 Jun 1984

• S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis

  Class II

  FDA 510(k) K951084 Active Cleared 31 May 1995

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