S-ROM ZT HA PROXIMAL FEMORAL SLEEVE— 510(k) K912713

Clearance details

Applicant

Joint Medical Products Corp.

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

1991-06-20

Decision date

1991-12-30

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Stamford, CT, US

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• 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

2,021

Total

2,021

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 →