LUMBAR FLEXION BRACE— 510(k) K810554

Substantially Equivalent

Orthomedics

FDA 510(k) clearance K810554 for LUMBAR FLEXION BRACE, Substantially Equivalent on 1981-03-13. Applicant: Orthomedics. Device class: 1.

Clearance details

Applicant: Orthomedics
Product code: Code IPY
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1981-03-02
Decision date: 1981-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code IPY

K823882 — M-BRACE1983-01-17
K823823 — LUMBOSACRAL SUPPORT1983-01-14
K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS1981-09-14
K812099 — CASH ORTHOSIS1981-08-13
K811494 — LUMBO-SACRAL FLEXION ORTHOSIS1981-06-16

More clearances from Orthomedics

K832740 — FEMORAL FRACTURE ORTHOSIS1983-09-20
K832741 — JASON CERVICAL ORTHOSIS1983-09-20
K832742 — EXTENSION CONTROL KNEE ORTHOSIS1983-09-20
K811456 — ORTHO-FRAC KIT1981-06-12
K811297 — CERVICAL SUPPORT1981-05-27

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