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FDA 510(k)

CALTRIX RESORBABLE BONE VOID FILLER

K-Number: K083279 · 2009-01-28

ApplicantAg Digital Technology Corp.
Decision Date2009-01-28
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALTRIX RESORBABLE BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Ag Digital Technology Corp.. It received FDA 510(k) clearance on 2009-01-28 under 510(k) number K083279. 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 CALTRIX RESORBABLE BONE VOID FILLER?

CALTRIX RESORBABLE BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2009-01-28. The listed applicant is Ag Digital Technology Corp.. The 510(k) number is K083279.

When did CALTRIX RESORBABLE BONE VOID FILLER receive FDA 510(k) clearance?

CALTRIX RESORBABLE BONE VOID FILLER received FDA 510(k) clearance on 2009-01-28, under 510(k) number K083279.

Who is the listed applicant for CALTRIX RESORBABLE BONE VOID FILLER?

The FDA 510(k) record lists Ag Digital Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALTRIX RESORBABLE BONE VOID FILLER?

The FDA product code for CALTRIX RESORBABLE BONE VOID FILLER is MQV.

Related Clinical Trials

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Other records listing Ag Digital Technology Corp. 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.

K121453A-GRIX TE RESORABLE BONE VOID FILLERK101641AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301K091688A-GRIX RESORBABLE 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.

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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