SMALL FRAGMENT PLATES AND SCREWS— 510(k) K951302

Clearance details

Applicant

Medpac

Product code

Code JDS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

1995-03-22

Decision date

1995-05-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

• K243608 — TRIGEN Stable Lock Nut & Washer2025-06-12
• K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System2024-09-20
• K241804 — TRIGEN INTERTAN 10S Nail System2024-08-22
• K233150 — NET BRAND Osteosynthesis Nailing System2024-02-20
• K230761 — TRIGEN META-NAIL Nail System2023-06-14

• K951303 — SFC1995-06-27
• K903697 — HAWAIIAN SUPRACONDYLAR PLATE1991-01-15

Injury

1,776

Malfunction

1,509

Total

3,285

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 →

• Z-0118-2020 — TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.Class II·Terminated·TriMed Inc.·20180824

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951302.