FDA.reportPublic FDA data

14x16mm, 6mmx0° KODIAK CERVICAL TRIAL

Primary DI
00819824027649
Brand
14x16mm, 6mmx0° KODIAK CERVICAL TRIAL
Company
MET 1 TECHNOLOGIES, LLC
Model
07-0030J
Catalog number
07-0030J
Device description
THE MET ONE TECHNOLOGIES KODIAK C SPINAL INTERVERTEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVERTEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE VERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. 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
00819824027649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824027649008198240276498198240276490819824027649

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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