ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW— 510(k) K903810

Name: FDA 510(k) clearance K903810
Creator: U.S. Food and Drug Administration
Published: 1990-10-16

Substantially Equivalent for Some Indications

Ace Medical Co.

FDA 510(k) clearance K903810 for ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW, Substantially Equivalent for Some Indications on 1990-10-16. Applicant: Ace Medical Co.. Device class: 2.

Clearance details

Applicant: Ace Medical Co.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1990-08-20
Decision date: 1990-10-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ace Medical Co.

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K972183 — DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL1997-08-26
K955472 — ACE HUMERUS & RADIUS PLATES1996-04-01
K955388 — ACE-DUPONT COMPOSITE RINGS1996-01-31
K954485 — 6.5MM SOLID CANCELLOUS BONE SCREW1995-10-31
K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS1995-10-12

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.