FDA.reportPublic FDA data

ZERO-P NATURAL

Primary DI
07612334096739
Brand
ZERO-P NATURAL
Company
Synthes GmbH
Model
03.617.021
Catalog number
03617021
Device description
ZERO-P NATURAL TRIAL SPACER PARALLEL/11MM
Published
2017-02-17
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
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152239000Zero-P Natural Plate SystemSynthes (Usa), LLC2015-12-02KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334096739Direct MarkingGS10
10705034811833PrimaryGS10
H981036170210SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334096739076123340967397612334096739
1070503481183310705034811833

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
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26
10886982064806NA03.000.076S03000076S2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168533SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168557SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168571SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168588SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168595SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168601SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168618SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168625SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168632SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168656SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168663SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168687SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168694SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168717SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168748SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168755SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168779SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168786SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168809SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168816SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168830SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168847SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168861SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168878SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168892SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168908SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168922SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168939SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169769SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169776SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27