Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BC Reflex Uni Knee System

K-Number: K212307 · 2021-10-12

ApplicantBodycad Laboratories, Inc.
Decision Date2021-10-12
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BC Reflex Uni Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K212307. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BC Reflex Uni Knee System?

BC Reflex Uni Knee System is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K212307.

When did BC Reflex Uni Knee System receive FDA 510(k) clearance?

BC Reflex Uni Knee System received FDA 510(k) clearance on 2021-10-12, under 510(k) number K212307.

Who is the listed applicant for BC Reflex Uni Knee System?

The FDA 510(k) record lists Bodycad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC Reflex Uni Knee System?

The FDA product code for BC Reflex Uni Knee System is HSX.

Other records listing Bodycad Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253300Fine Osteotomy™K250394Fine TTO™K250923Fine Osteotomy™K241356Fine Osteotomy™K240703Fine Osteotomy™K240066Fine Osteotomy™

View all 16 devices →

Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑