FDA.reportPublic FDA data

KODIAK CORPECTOMY IMPLANT, 12x14mm, 55mmx6°

Primary DI
00819824026888
Brand
KODIAK CORPECTOMY IMPLANT, 12x14mm, 55mmx6°
Company
MET 1 TECHNOLOGIES, LLC
Model
41552406K
Catalog number
41552406K
Device description
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
Published
2023-04-07
Public version status
New
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
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222806000Kodiak C Spinal Implant SystemMet One Technologies, LLC2022-12-22ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819824026888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824026888008198240268888198240268880819824026888

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height55Millimeter
Length12Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9154726762yone@met1tech.com

Regulatory Flags#

DUNS number
080474650
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819824024129CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010012600100122019-03-06
00819824024136CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010014600100142019-03-06
00819824024143CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010016600100162019-03-06
00819824024150CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010018600100182019-03-06
00819824024167CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010020600100202019-03-06
00819824024174CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010022600100222019-03-06
00819824024181CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010024600100242019-03-06
00819824024198CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020024600200242019-03-06
00819824024204CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020026600200262019-03-06
00819824024211CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020028600200282019-03-06
00819824024228CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020030600200302019-03-06
00819824024235CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020032600200322019-03-06
00819824024242CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020034600200342019-03-06
00819824024259CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020037600200372019-03-06
00819824024266CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020040600200402019-03-06
00819824024273CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020043600200432019-03-06
00819824024280CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020046600200462019-03-06
00819824024297CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030039600300392019-03-06
00819824024303CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030042600300422019-03-06
00819824024310CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030045600300452019-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536212989ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212996ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213009ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213016ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213023ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212804Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212811Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212828Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212835Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212842Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212859Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212866Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212873Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212880Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212897Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212903Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212910Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212927Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212934Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212941Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212958Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212965Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212972Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
00763000857936T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-02-27
00810141048478Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048485Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048492Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048508Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048515Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048577Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26