FDA.reportPublic FDA data

Zero-P

Primary DI
H981036177550
Brand
Zero-P
Company
Synthes GmbH
Model
03.617.755
Catalog number
03617755
Device description
ZERO-P TRIAL SPACER/LORDOTIC 5MM HEIGHT
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819932869Direct MarkingGS10
10705034716855PrimaryGS10
H981036177550SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819932869076118199328697611819932869
1070503471685510705034716855

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
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
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
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391560CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391577CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391584CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391591CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391607CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391614CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391621CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391638CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391645CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391652CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391669CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391676CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391553CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-08
00810017916450Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00763000880477|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-06-22