RAYLOR(TM) DRILL STOP— 510(k) K873692

Name: FDA 510(k) clearance K873692
Creator: U.S. Food and Drug Administration
Published: 1987-12-17

Substantially Equivalent

Cedar Surgical, Inc.

FDA 510(k) clearance K873692 for RAYLOR(TM) DRILL STOP, Substantially Equivalent on 1987-12-17. Applicant: Cedar Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Cedar Surgical, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 1987-09-08
Decision date: 1987-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cedar Surgical, Inc.

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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
K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS1986-11-26

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.