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)

Montage-XT Settable, Resorbable Bone Putty

K-Number: K233566 · 2024-08-21

ApplicantOrthocon, Inc.
Decision Date2024-08-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Montage-XT Settable, Resorbable Bone Putty is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K233566. 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 Montage-XT Settable, Resorbable Bone Putty?

Montage-XT Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Orthocon, Inc.. The 510(k) number is K233566.

When did Montage-XT Settable, Resorbable Bone Putty receive FDA 510(k) clearance?

Montage-XT Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2024-08-21, under 510(k) number K233566.

Who is the listed applicant for Montage-XT Settable, Resorbable Bone Putty?

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

What is the FDA product code for Montage-XT Settable, Resorbable Bone Putty?

The FDA product code for Montage-XT Settable, Resorbable Bone Putty is MQV.

Other records listing Orthocon, Inc. 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.

K261265Permatage XT Settable Bone PuttyK261439Permatage Flowable, Settable Hemostatic Bone PasteK253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)K253732Permatage Flowable, Settable Bone PasteK253854MONTAGE XT Cranial CementK243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

View all 24 devices →

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.

↑