CANCELLOUS BONE SCREW— 510(k) K934615

Name: FDA 510(k) clearance K934615
Creator: U.S. Food and Drug Administration
Published: 1994-04-25

Substantially Equivalent for Some Indications

Onyx Medical Corp.

FDA 510(k) clearance K934615 for CANCELLOUS BONE SCREW, Substantially Equivalent for Some Indications on 1994-04-25. Applicant: Onyx Medical Corp.. Device class: 2.

Clearance details

Applicant: Onyx Medical Corp.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-09-27
Decision date: 1994-04-25
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Onyx Medical Corp.

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K942022 — FACE-IT SHIELD1994-07-08
K931690 — SPOON PLATE1994-06-07
K931680 — CANNULATED CANCELLOUS SCREW1994-05-04
K931684 — EPIPHYSIS PLATE1994-05-04
K931692 — T-PLATE1994-05-04

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.