J.B.S. SELF-TAPPING THREADED PIN— 510(k) K940673

Name: FDA 510(k) clearance K940673
Creator: U.S. Food and Drug Administration
Published: 1994-11-14

Substantially Equivalent

J.B.S., S.A.

FDA 510(k) clearance K940673 for J.B.S. SELF-TAPPING THREADED PIN, Substantially Equivalent on 1994-11-14. Applicant: J.B.S., S.A.. Device class: 2.

Clearance details

Applicant: J.B.S., S.A.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1994-02-16
Decision date: 1994-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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K955864 — J.B. S. C1-C2 CLAMP1996-03-15
K953881 — SPINE SYSTEM SACRAL PLATE1996-02-21
K953599 — CLAMP ASSEMBLY1995-12-19
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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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 →

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