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FDA 510(k)

EBI LACTOSORB GRAFT CONTAINMENT SYSTEM

K-Number: K033918 · 2004-08-16

ApplicantEbi, L.P.
Decision Date2004-08-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI LACTOSORB GRAFT CONTAINMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K033918. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI LACTOSORB GRAFT CONTAINMENT SYSTEM?

EBI LACTOSORB GRAFT CONTAINMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Ebi, L.P.. The 510(k) number is K033918.

When did EBI LACTOSORB GRAFT CONTAINMENT SYSTEM receive FDA 510(k) clearance?

EBI LACTOSORB GRAFT CONTAINMENT SYSTEM received FDA 510(k) clearance on 2004-08-16, under 510(k) number K033918.

Who is the listed applicant for EBI LACTOSORB GRAFT CONTAINMENT SYSTEM?

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

What is the FDA product code for EBI LACTOSORB GRAFT CONTAINMENT SYSTEM?

The FDA product code for EBI LACTOSORB GRAFT CONTAINMENT SYSTEM is HRS.

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Other records listing Ebi, L.P. as applicant

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K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL SYSTEM

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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