FDA.reportPublic FDA data

SYNFIX Evolution

Primary DI
H98108815366S0
Brand
SYNFIX Evolution
Company
SYNTHES (U.S.A.) LP
Model
08.815.366S
Catalog number
08815366S
Device description
SYNFIX® EVOLUTION SPACER LARGE/19MM HEIGHT/18°-STER
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10705034814636PrimaryGS10
H98108815366S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503481463610705034814636

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
832637081
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00643169511873MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511880MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511897MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511903MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511910MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511927MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511934MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511941MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511958MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511965MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512016MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512030MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512047MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512054SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512061MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512078MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512085MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511705MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-17