FDA.reportPublic FDA data

CONCERO FACET SCREW SYSTEM

Primary DI
00888480528074
Brand
CONCERO FACET SCREW SYSTEM
Company
BIOMET SPINE LLC
Model
7521-4060
Catalog number
7521-4060
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480528074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480528074008884805280748884805280740888480528074

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00081013188039 ION AO Coupling Cannulated Handle Surgentec, LLCMRW2026-03-09
00810131880330"T-Handle 3/16"" Connection"Surgentec, 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