FDA.reportPublic FDA data

NA

Primary DI
H9814953960
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
495.396
Catalog number
495396
Device description
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI)
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZXMesh, surgical, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZXMesh, Surgical, MetalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034785561PrimaryGS10
H9814953960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503478556110705034785561

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
832637081
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
false
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
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000855444Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855451Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855468Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855475Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855499Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856403Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856410Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856458Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856465Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856397PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-25
00763000856472Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856489Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856502Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856519Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856526Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856533Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856557Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856564Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856571Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856588Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856595Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856625Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856632Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856649Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000855260PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855284PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855291PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855307PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855314PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855321PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10