ACROMED INTERBODY DEPTH GAUGES— 510(k) K873191

Name: FDA 510(k) clearance K873191
Creator: U.S. Food and Drug Administration
Published: 1987-09-09

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K873191 for ACROMED INTERBODY DEPTH GAUGES, Substantially Equivalent on 1987-09-09. Applicant: Buckman Co., Inc.. Device class: 1.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code HTJ
Device class: Class 1
Regulation: 21 CFR 888.4300
Advisory panel: Orthopedic
Date received: 1987-08-13
Decision date: 1987-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTJ

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K940480 — ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE1994-03-23
K925335 — ACUFEX INTRA ARTICULAR MEASURING DEVICE1992-12-29
K864426 — RAYLOR(TM) DEPTH GAUGE1986-11-26

More clearances from Buckman Co., Inc.

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K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM1998-06-25
K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM1998-06-08
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 HTJ

product code HTJ

Malfunction: 2,320
Total: 2,320

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.