TIBIAL FRACTURE BRACE— 510(k) K802871

Substantially Equivalent

Orthomedics

FDA 510(k) clearance K802871 for TIBIAL FRACTURE BRACE, Substantially Equivalent on 1980-12-11. Applicant: Orthomedics. Device class: 1.

Clearance details

Applicant: Orthomedics
Product code: Code IQI
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1980-11-14
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Orthomedics

K832740 — FEMORAL FRACTURE ORTHOSIS1983-09-20
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K811456 — ORTHO-FRAC KIT1981-06-12
K811297 — CERVICAL SUPPORT1981-05-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.