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)

CarriGen PF

K-Number: K182107 · 2018-08-31

ApplicantEtex Corporation
Decision Date2018-08-31
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarriGen PF is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corporation. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K182107. 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 CarriGen PF?

CarriGen PF is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Etex Corporation. The 510(k) number is K182107.

When did CarriGen PF receive FDA 510(k) clearance?

CarriGen PF received FDA 510(k) clearance on 2018-08-31, under 510(k) number K182107.

Who is the listed applicant for CarriGen PF?

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

What is the FDA product code for CarriGen PF?

The FDA product code for CarriGen PF is MQV.

Other records listing Etex Corporation 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.

K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )

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.

↑