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)

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

K-Number: K254210 · 2026-09-25

ApplicantHyundai Bioland Co., Ltd.
Decision Date2026-09-25
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is the device name listed in this FDA 510(k) record. The listed applicant is Hyundai Bioland Co., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254210. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Hyundai Bioland Co., Ltd.. The 510(k) number is K254210.

When did REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) receive FDA 510(k) clearance?

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254210.

Who is the listed applicant for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

The FDA 510(k) record lists Hyundai Bioland Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

The FDA product code for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is NPM.

Related Devices (Code: NPM)

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.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, 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.

↑