FDA.reportPublic FDA data

ANTEGRA-T

Primary DI
10705034732930
Brand
ANTEGRA-T
Company
Synthes GmbH
Model
04.102.045S
Catalog number
04102045S
Device description
TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-LUMBAR
Published
2015-09-14
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

Contact Domains#

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
K081568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081568000ANTEGRA-TSynthes Spine Co.Lp2008-09-02KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034732930PrimaryGS10
H98104102045S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503473293010705034732930

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
10889981142117MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142124MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142148MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142155MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142179MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142186MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142193MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142209MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142216MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142223MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142230MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142247MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142254MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142261MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142278MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142285MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142292MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981182717MarinerSeaspine Orthopedics CorporationKWQ2019-10-24