FDA.reportPublic FDA data

6.5/7.0 Drill Bit

Primary DI
00810131881252
Brand
6.5/7.0 Drill Bit
Company
Surgentec, LLC
Model
SR12-6442
Device description
SR12- ION Facet Screw System
Published
2026-03-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243265000Ion 3DSurGenTec, LLC2024-12-04MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131881252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131881252008101318812528101318812520810131881252

GMDN Terms#

Term, Definition table
TermDefinition
Facet joint prosthesisA sterile implantable device intended to resurface and/or replace a degenerative or otherwise diseased vertebral facet (apophyseal, zygapophyseal) joint. It typically consists of small plate-like metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] device intended to be fixed to the superior and inferior articulating surfaces of the joint. Fixation may be by means of a trans-laminar or trans-facet screw or bolt.

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
00810131881061 BMAC Bevel Needle SR07-1500AAN-11-BMACS2025-01-03
00810131880941 BMAN Solid Diamond Needle SR07-1100AAN-09-BMANS2024-12-31
00810131880958 BMAN Solid Diamond Needle Kit SR07-1101AAN-09-BMAN2024-12-31
00810131880965BMAN Solid Diamond Needle - Two Pack SR07-1102AAN-09-2BMANS2024-12-31
00810131880972BMAN Solid Diamond Needle Kit - Two Pack SR07-1103AAN-09-2BMAN2024-12-31
00810131881009 BMAC Diamond Needle SR07-1300AAN-09-BMACS2024-12-31
00850040139587"SI Guidewire 9"""SR16-5001SI-P-GP2024-08-16
00810131880583 Mallet - Large - Large HeadSR99-60002024-12-10
00810131880590 Mallet - Large - Small HeadSR99-60012024-12-10
00810131880606"1/4"" Square Drill Chuck"SR99-60022024-12-10
00810131880729 Bone Chisel SR99-60032024-12-10
00858406007181OsteoFlo Synthetic NanoPutty Syringe- 1ccONP-S-012020-11-19
00858406007198OsteoFlo Synthetic NanoPutty Syringe- 2.5ccONP-S-022020-11-19
00858406007204OsteoFlo Synthetic NanoPutty Syringe- 510ccONP-S-102020-11-19
00858406007211OsteoFlo Synthetic NanoPutty Syringe- 5ccONP-S-052020-11-19
00858406007228OsteoFlo Synthetic NanoPutty Cartridge- 5ccONP-T-5002020-11-18
00858406007235OsteoFlo Synthetic NanoPutty Cartridge- 10ccONP-T-10002020-11-19
00081013188039 ION AO Coupling Cannulated Handle SR12-50062026-03-09
00810131880330"T-Handle 3/16"" Connection"SR11-50022026-03-09
00810131881429OsteoFlo HydroFiber - 1cc LabeledHF-OSF-012026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800039819909FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
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08800039820325FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820332FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820349FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039821391FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823739FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823746FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823753FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823760FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823777FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823784FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823791FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039823807FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
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