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FDA 510(k)

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER

K-Number: K071155 · 2007-07-03

ApplicantScience For Biomaterials
Decision Date2007-07-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Science For Biomaterials. It received FDA 510(k) clearance on 2007-07-03 under 510(k) number K071155. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER?

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER is a medical device that received FDA 510(k) clearance on 2007-07-03. The listed applicant is Science For Biomaterials. The 510(k) number is K071155.

When did MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER receive FDA 510(k) clearance?

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER received FDA 510(k) clearance on 2007-07-03, under 510(k) number K071155.

Who is the listed applicant for MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER?

The FDA 510(k) record lists Science For Biomaterials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER?

The FDA product code for MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER is MQV.

Related Clinical Trials

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.

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Other records listing Science For Biomaterials 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.

K120818OTIS-C PLUSK090994LIGAFIX INTERFACE SCREWK070507MODIFICATION TO: LIGAFIX INTERFERENCE SCREWK061022BIO 1-KIT BIOSORB FILLED CARTRIDGE

Related Devices (Code: MQV)

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.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

Official Source

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

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