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FDA 510(k)

Cerament Bone Void Filler

K-Number: K201535 · 2020-10-16

ApplicantBonesupport AB
Decision Date2020-10-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cerament Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Bonesupport AB. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K201535. 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 Cerament Bone Void Filler?

Cerament Bone Void Filler is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Bonesupport AB. The 510(k) number is K201535.

When did Cerament Bone Void Filler receive FDA 510(k) clearance?

Cerament Bone Void Filler received FDA 510(k) clearance on 2020-10-16, under 510(k) number K201535.

Who is the listed applicant for Cerament Bone Void Filler?

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

What is the FDA product code for Cerament Bone Void Filler?

The FDA product code for Cerament Bone 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.

NCT07270380Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.RECRUITING

Other records listing Bonesupport AB 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.

K234008CERAMENT GK240459Cerament Bone Void Filler

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.

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.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, 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.

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