RAYLOR(TM) DEPTH GAUGE— 510(k) K864426

Name: FDA 510(k) clearance K864426
Creator: U.S. Food and Drug Administration
Published: 1986-11-26

Substantially Equivalent

Cedar Surgical, Inc.

FDA 510(k) clearance K864426 for RAYLOR(TM) DEPTH GAUGE, Substantially Equivalent on 1986-11-26. Applicant: Cedar Surgical, Inc.. Device class: 1.

Clearance details

Applicant: Cedar Surgical, Inc.
Product code: Code HTJ
Device class: Class 1
Regulation: 21 CFR 888.4300
Advisory panel: Orthopedic
Date received: 1986-11-10
Decision date: 1986-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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
K873191 — ACROMED INTERBODY DEPTH GAUGES1987-09-09

More clearances from Cedar Surgical, Inc.

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K873692 — RAYLOR(TM) DRILL STOP1987-12-17
K872281 — RAYLOR FUSION FUNNEL1987-11-02
K873690 — CEDAR(TM) PELVIC CUSHION1987-10-26
K873691 — CEDAR(TM) RETRACTOR RING1987-09-28
K864425 — RAYLOR(TM) DISSECTING HOOK1986-12-12

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.