FDA.reportPublic FDA data

4.5mm Drill Bit - Long

Primary DI
00858406007594
Brand
4.5mm Drill Bit - Long
Company
Surgentec, LLC
Model
SR12-6011
Device description
SR12- ION Facet Screw System
Published
2024-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00858406007594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007594008584060075948584060075940858406007594

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131884055TiLink-L Rescue Drill GuideSR21-27002026-09-25
00810131884062TiLink-L Rescue DilatorSR21-67012026-09-25
00810131884079TiLink-L Rescue Impact CapSR21-67022026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSR21-67032026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSR21-70202026-09-25
00810131884864TiLink-L Rescue CaddySR21-70212026-09-25
00810131882983BMAN BCOR Bone Marrow Aspirate KitAAN-09-BCORES2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)AAN-09-BCORE2026-08-19
00810131885045ION Non CervicalSR17-10002026-07-28
00810131881795ION Disposable Instrument KitTI-K-10002026-03-09
00810131881801ION 55 Facet Implant - SterileTI-K-552026-03-09
00810131881818ION 60 Facet Implant - SterileTI-K-602026-03-09
00810131881825ION 65 Facet Implant - SterileTI-K-652026-03-09
00810131882433ION-C Navigation LocatorSR12-25122026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSR12-65102026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSR12-65112026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSR12-65092026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSR21-63052026-07-06
00810131882556TiLink-L Navigation Drill GuideSR21-63012026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSR21-63042026-07-06

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Primary DI, Brand, Company table
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00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
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00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
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00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
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00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
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00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614819Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614826Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614833Arthrex®ARTHREX, INC.MRW2026-10-07