FDA.reportPublic FDA data

N/A

Primary DI
08800043965197
Brand
N/A
Company
TDM Co., Ltd.
Model
2212-0250
Catalog number
2212-0250
Device description
Cervical Plate, 2 Level 50mm x 1.97mm
Published
2026-06-05
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
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240423000TDM Anterior Cervical Plate SystemTdm Co., Ltd.2024-04-08KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800043965197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800043965197088000439651978800043965197

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
557801921
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08800043949180N/A2212-02442212-02442026-06-05
08800043965029N/A2212-01182212-01182026-06-05
08800043965036N/A2212-01202212-01202026-06-05
08800043965043N/A2212-01222212-01222026-06-05
08800043965050N/A2212-01242212-01242026-06-05
08800043965067N/A2212-01262212-01262026-06-05
08800043965074N/A2212-01282212-01282026-06-05
08800043965081N/A2212-01302212-01302026-06-05
08800043965098N/A2212-01322212-01322026-06-05
08800043965104N/A2212-01342212-01342026-06-05
08800043965111N/A2212-02322212-02322026-06-05
08800043965128N/A2212-02342212-02342026-06-05
08800043965135N/A2212-02362212-02362026-06-05
08800043965142N/A2212-02382212-02382026-06-05
08800043965159N/A2212-02402212-02402026-06-05
08800043965166N/A2212-02422212-02422026-06-05
08800043965173N/A2212-02462212-02462026-06-05
08800043965180N/A2212-02482212-02482026-06-05
08800043965203N/A2212-02522212-02522026-06-05
08800043965210N/A2212-02542212-02542026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
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00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05