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FDA 510(k)

E-MATRIX GRAFT BONE EXTENDER

K-Number: K083449 · 2009-06-12

ApplicantPioneer Surgical Technology
Decision Date2009-06-12
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E-MATRIX GRAFT BONE EXTENDER is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K083449. 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 E-MATRIX GRAFT BONE EXTENDER?

E-MATRIX GRAFT BONE EXTENDER is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K083449.

When did E-MATRIX GRAFT BONE EXTENDER receive FDA 510(k) clearance?

E-MATRIX GRAFT BONE EXTENDER received FDA 510(k) clearance on 2009-06-12, under 510(k) number K083449.

Who is the listed applicant for E-MATRIX GRAFT BONE EXTENDER?

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

What is the FDA product code for E-MATRIX GRAFT BONE EXTENDER?

The FDA product code for E-MATRIX GRAFT BONE EXTENDER is MQV.

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Other records listing Pioneer Surgical Technology 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.

K110561FORTROSS BONE VOID FILLERK101790QUANTUM SPINAL SYSTEM, QUANTUM MISK101525PIONEER SPINOUS PROCESS FUSION PLATEK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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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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