S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG— 510(k) K931676

Clearance details

Applicant

Joint Medical Products Corp.

Product code

Code JDL

Device class

Class 3

Regulation

21 CFR 888.3320

Advisory panel

Orthopedic

Date received

1993-04-06

Decision date

1994-05-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stamford, CT, US

• K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES2008-08-07
• K070785 — DYNASTY ACETABULAR SYSTEM2007-07-11
• K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER2006-12-06
• K051995 — PROFEMUR RENAISSANCE HIP STEM2005-08-22
• K051348 — CONSERVE TOTAL FEMORAL HEAD2005-08-19

• K955511 — ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP1996-02-26
• K954935 — S-ROM FEMORAL HIP STEM - SIZE 14 X 81996-01-22
• K944321 — S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II1995-08-14
• K951726 — S-ROM ZTP UHMWPE ACETABULAR CUP1995-06-21
• K951084 — S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS1995-05-31

Injury

285

Total

285

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →