FDA.report

CONCERO FACET SCREW SYSTEM

Primary DI
00888480527770
Brand
CONCERO FACET SCREW SYSTEM
Company
BIOMET SPINE LLC
Model
7519-4545
Catalog number
7519-4545
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications

CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888480527770PrimaryGS10

GMDN Terms

TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags

DUNS number
018577570
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
03662663063296Vital Spinal Fixation System727M84002024-05-10
03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

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Primary DIBrandCompanyProduct codePublished
00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCMRW2026-03-09
00810131880330T-Handle 3/16" ConnectionSURGENTEC, LLCMRW2026-03-09
00810131881252 6.5/7.0 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881726ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
00810131881788ION Cervical Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881795ION Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881832 7.5 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881856ION Metal Drill Guide - LargeSURGENTEC, LLCMRW2026-03-09
00810131881986 ION Caddy with Metal PlateSURGENTEC, LLCMRW2026-03-09
00810131882051 Facet Locator - LargeSURGENTEC, LLCMRW2026-03-09
00810131882068 Impactor LargeSURGENTEC, LLCMRW2026-03-09
00810131882075Serrated Rasp - LargeSURGENTEC, LLCMRW2026-03-09
00810131882174ION Large TraySURGENTEC, LLCMRW2026-03-09
00810131882402 6.0mm Drill BitSURGENTEC, LLCMRW2026-03-09
00810131882419Plastic Removal Sleeve - Standard - 7.0-7.5SURGENTEC, LLCMRW2026-03-09
00810131882426Plastic Removal Sleeve - Standard - 5.5-6.5SURGENTEC, LLCMRW2026-03-09
00810131882723ION Cervical TraySURGENTEC, LLCMRW2026-03-09
00810131882747ION Lumbar TraySURGENTEC, LLCMRW2026-03-09
00810131882754ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
03760418040667FFX Screw SC MEDICAMRW2025-11-26
03760418040674FFX Screw SC MEDICAMRW2025-11-26
03760418040681FFX Screw SC MEDICAMRW2025-11-26
03760418040698FFX Screw SC MEDICAMRW2025-11-26
03760418040704FFX Screw SC MEDICAMRW2025-11-26
03760418040711FFX Screw SC MEDICAMRW2025-11-26
03760418040728FFX Screw SC MEDICAMRW2025-11-26
03760418040735FFX Screw SC MEDICAMRW2025-11-26