FDA.reportPublic FDA data

SYNFIX Evolution

Primary DI
07612334154705
Brand
SYNFIX Evolution
Company
Synthes GmbH
Model
03.835.413
Catalog number
03835413
Device description
SYNFIX® EVOLUTION MINI-OPEN DRIVER W/O THREAD LOCK SLEEVE
Published
2019-12-20
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
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150673000SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015-08-21OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334154705Direct MarkingGS10
10705034821382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334154705076123341547057612334154705
1070503482138210705034821382

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
10886982239297NA519.51519512017-02-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982313524ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313531ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313548ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313555ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313562ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00889095311532INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311549INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311556INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311563INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311570INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311587INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19