FDA.reportPublic FDA data

ION Cervical Disposable Instrument Kit

Primary DI
00810131881788
Brand
ION Cervical Disposable Instrument Kit
Company
Surgentec, LLC
Model
TI-C-1000
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K241416000
K243265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241416000Ion 3DSurGenTec, LLC2024-06-17MRW
K243265000Ion 3DSurGenTec, LLC2024-12-04MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131881788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131881788008101318817888101318817880810131881788

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

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccOHFP-S-012025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccOHFP-S-032025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccOHFP-S-062025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccOHFP-S-122025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALONP-S-05 - IB2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALONP-S-10 - IB2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALOHFP-S-06-IB2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALOHFP-S-12-IB2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccONP-K-5002025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccONP-K-10002025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccONP-U-012025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccONP-U-022025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccONP-U-052025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccONP-U-102025-06-10
00810131880545Global Tip Adapter - LongGG-NTA-122025-03-14
00810131881191Global Tip Adapter - NarrowGG-NTA-142025-03-14
00810131881207Bullet Global Tip AdapterGG-NTA-132025-03-14
00858406007150Bullet Tip AdapterGG-NTA-032025-03-14

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00852776006751CORUS PCSS 3D-T LevelOne, 4mmProvidence Medical Technology, Inc.MRW2026-10-26
00888867614543Arthrex®ARTHREX, INC.MRW2026-10-07
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