MODIFICATION TO:SBI RINGFIX— 510(k) K071394

Name: FDA 510(k) clearance K071394
Creator: U.S. Food and Drug Administration
Published: 2007-06-29

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K071394 for MODIFICATION TO:SBI RINGFIX, Substantially Equivalent on 2007-06-29. Applicant: Small Bone Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2007-05-21
Decision date: 2007-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

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 →

Recalls naming K071394

K-number listed on FDA's recall record

Z-1720-2014 — SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.Class II·Terminated·Small Bone Innovations, Inc.·20140407

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071394.

Data sourced from openFDA. This site is unofficial and independent of the FDA.