ACROMED ADS BONE NAIL DRIVER— 510(k) K875054

Name: FDA 510(k) clearance K875054
Creator: U.S. Food and Drug Administration
Published: 1988-01-28

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K875054 for ACROMED ADS BONE NAIL DRIVER, Substantially Equivalent on 1988-01-28. Applicant: Buckman Co., Inc.. Device class: 1.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code HWR
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1987-12-09
Decision date: 1988-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

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K915776 — KNEE PROSTHESIS DRIVER1992-06-11
K870847 — SCHULTZ PHALANGEAL COMPONENT DRIVER1987-03-13
K870848 — SCHULTZ METACARPAL COMPONENT DRIVER1987-03-13

More clearances from Buckman Co., Inc.

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K964252 — ORTHOCHUCK1997-05-27
K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM1997-01-16
K960451 — WEBB-MORLEY SPINE SYSTEM1996-04-18

Adverse events under product code HWR

product code HWR

Malfunction: 6,549
Total: 6,549

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.