FDA.reportPublic FDA data

SYNFIX Evolution

Primary DI
H9810483523002S
Brand
SYNFIX Evolution
Company
SYNTHES (U.S.A.) LP
Model
04.835.230.02S
Catalog number
0483523002S
Device description
SYNFIX® EVOLUTION SCREW/30MM STERILE
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
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
20705034816163PrimaryGS10
H9810483523002SSecondaryHIBCC0
80705034816165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503481616320705034816163
8070503481616580705034816165

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
10705034731650NA03.820.126038201262016-12-31
10705034731667NA03.820.127038201272016-12-31
10705034731674NA03.820.128038201282016-12-31
10705034731681NA03.820.129038201292016-12-31
10705034731759NA03.820.136038201362016-12-31
10705034731766NA03.820.137038201372016-12-31
10705034731896PRODISC L03.820.201038202012016-12-31
10705034731902PRODISC L03.820.202038202022016-12-31
10705034732008NA03.820.459038204592016-12-31
10705034732015NA03.820.462038204622016-12-31
10705034763729ProDisc-C09.820.025S09820025S2014-09-08
10705034763736ProDisc-C09.820.026S09820026S2014-09-08
10705034763750ProDisc-C09.820.035S09820035S2014-09-08
10705034763767ProDisc-C09.820.036S09820036S2014-09-08
10705034763781ProDisc-C09.820.045S09820045S2014-09-08
10705034763798ProDisc-C09.820.046S09820046S2014-09-08
10705034763804ProDisc-C09.820.047S09820047S2014-09-08
10705034763811ProDisc-C09.820.055S09820055S2014-09-08
10705034763828ProDisc-C09.820.056S09820056S2014-09-08
10705034763835ProDisc-C09.820.057S09820057S2014-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074067ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074074ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074081ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074098ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074104ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074111ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074128ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074135ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074180ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074241ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074272ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074302ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074319ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29