ORTHOPEDIC FORCEPS— 510(k) K780397

Name: FDA 510(k) clearance K780397
Creator: U.S. Food and Drug Administration
Published: 1978-03-22

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K780397 for ORTHOPEDIC FORCEPS, Substantially Equivalent on 1978-03-22. Applicant: Orthopedic Equipment Co., Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code HTX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1978-03-13
Decision date: 1978-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTX

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K874954 — MANUAL RONGEUR1987-12-30
K841620 — FRONT RADIUS CUTTER1984-09-20
K841621 — BACK RADIUS CUTTER1984-09-20
K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC1976-08-03

More clearances from Orthopedic Equipment Co., Inc.

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K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM1984-06-19
K841189 — OEC/REZAIAN SPINAL FIXATOR1984-05-16
K800530 — SCHLEIN TRI-SURFACE ANKLE1980-04-02
K781445 — SPREADER1979-09-27
K790209 — FILTER SYSTEM, ALTNER DISPOSABLE1979-02-26

Adverse events under product code HTX

product code HTX

Other: 1
Total: 1

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.