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FDA 510(k)

BIO-OSS

K-Number: K952617 · 1995-08-07

ApplicantGeistlich-Pharma
Decision Date1995-08-07
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-OSS is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich-Pharma. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K952617. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-OSS?

BIO-OSS is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Geistlich-Pharma. The 510(k) number is K952617.

When did BIO-OSS receive FDA 510(k) clearance?

BIO-OSS received FDA 510(k) clearance on 1995-08-07, under 510(k) number K952617.

Who is the listed applicant for BIO-OSS?

The FDA 510(k) record lists Geistlich-Pharma as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-OSS?

The FDA product code for BIO-OSS is LYC.

Other records listing Geistlich-Pharma 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.

K033815BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENK014289ORTHOSS RESORBABLE BONE VOID FILLERK970569BIO-BLOCKSK974399BIO-OSS COLLAGENK970321BIO-OSS ANORGANIC BOVINE BONEK972817RESOR-PIN RESORBABLE MEMBRANE PIN

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

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