FDA.reportPublic FDA data

SYNFIX Evolution

Primary DI
H9810483512002S0
Brand
SYNFIX Evolution
Company
SYNTHES (U.S.A.) LP
Model
04.835.120.02S
Catalog number
0483512002S
Device description
SYNFIX® EVOLUTION FINE TIP SCREW/20MM - STERILE
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
20705034816118PrimaryGS10
H9810483512002S0SecondaryHIBCC0
80705034816110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503481611820705034816118
8070503481611080705034816110

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
832637081
Device count
2
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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214616MeridianSeaspine Orthopedics CorporationOVD2020-12-30