FDA.reportPublic FDA data

12x14mm, 6° KODIAK CORPECTOMY TRIAL

Primary DI
00819824027472
Brand
12x14mm, 6° KODIAK CORPECTOMY TRIAL
Company
MET 1 TECHNOLOGIES, LLC
Model
07-0013G
Catalog number
07-0013G
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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

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
00819824027472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824027472008198240274728198240274720819824027472

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081982402890507x22x6° KODIAK PLIF TRIAL04-2207P604-2207P62023-09-29
0081982402891208x22x6° KODIAK PLIF TRIAL04-2208P604-2208P62023-09-29
0081982402892909x22x6° KODIAK PLIF TRIAL04-2209P604-2209P62023-09-29
0081982402893610x22x6° KODIAK PLIF TRIAL04-2210P604-2210P62023-09-29
0081982402894311x22x6° KODIAK PLIF TRIAL04-2211P604-2211P62023-09-29
0081982402895012x22x6° KODIAK PLIF TRIAL04-2212P604-2212P62023-09-29
0081982402896713x22x6° KODIAK PLIF TRIAL04-2213P604-2213P62023-09-29
0081982402897414x22x6° KODIAK PLIF TRIAL04-2214P604-2214P62023-09-29
0081982402898115x22x6° KODIAK PLIF TRIAL04-2215P604-2215P62023-09-29
0081982402899816x22x6° KODIAK PLIF TRIAL04-2216P604-2216P62023-09-29
0081982402900107x26x6° KODIAK PLIF TRIAL04-2607P604-2607P62023-09-29
0081982402901808x26x6° KODIAK PLIF TRIAL04-2608P604-2608P62023-09-29
0081982402902509x26x6° KODIAK PLIF TRIAL04-2609P604-2609P62023-09-29
0081982402903210x26x6° KODIAK PLIF TRIAL04-2610P604-2610P62023-09-29
0081982402904911x26x6° KODIAK PLIF TRIAL04-2611P604-2611P62023-09-29
0081982402905612x26x6° KODIAK PLIF TRIAL04-2612P604-2612P62023-09-29
0081982402906313x26x6° KODIAK PLIF TRIAL04-2613P604-2613P62023-09-29
0081982402907014x26x6° KODIAK PLIF TRIAL04-2614P604-2614P62023-09-29
0081982402908715x26x6° KODIAK PLIF TRIAL04-2615P604-2615P62023-09-29
0081982402909416x26x6° KODIAK PLIF TRIAL04-2616P604-2616P62023-09-29

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