MINIFIX— 510(k) K964094

Clearance details

Applicant

Ferguson Medical

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

1996-10-11

Decision date

1996-11-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chico, CA, US

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• K253291 — Excelsior System2026-01-20
• K253202 — Hoffmann LRF System2025-12-19

• K033153 — DICOM THEATER2004-04-23
• K962615 — TUMORLOCALIZER MRI1998-03-19
• K963794 — PUNCTURENEEDLE1998-03-19
• K971813 — EMBLA1998-01-16
• K972217 — ORTHOPEDIC SCREW SYSTEM1997-11-20

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

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 →