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FDA 510(k)

Osteocera Resorbable Bone Substitute

K-Number: K180758 · 2018-10-24

ApplicantWiltrom Corporation Limited
Decision Date2018-10-24
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Osteocera Resorbable Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Wiltrom Corporation Limited. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K180758. 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 Osteocera Resorbable Bone Substitute?

Osteocera Resorbable Bone Substitute is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Wiltrom Corporation Limited. The 510(k) number is K180758.

When did Osteocera Resorbable Bone Substitute receive FDA 510(k) clearance?

Osteocera Resorbable Bone Substitute received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180758.

Who is the listed applicant for Osteocera Resorbable Bone Substitute?

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

What is the FDA product code for Osteocera Resorbable Bone Substitute?

The FDA product code for Osteocera Resorbable Bone Substitute 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.

NCT07646795Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative StudyACTIVE_NOT_RECRUITING

Other records listing Wiltrom Corporation Limited 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.

K202894Wiltrom Spinal Fixation SystemK172237Bicera Resorbable Bone SubstituteK172548Wiltrom Spinal Fixation System

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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