NewPrim System— 510(k) K191966

Substantially Equivalent

Brm Extremities

FDA 510(k) clearance K191966 for NewPrim System, Substantially Equivalent on 2020-02-13. Applicant: Brm Extremities. Device class: 2.

Clearance details

Applicant: Brm Extremities
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 2019-07-23
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, MI, US

Download summary PDF View on FDA.gov ↗

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K102601 — ORTHOFLEX ROD2011-01-14
K023531 — LESSER METATARSAL PHALANGEAL JOINT IMPLANT2003-01-17

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