FDA.reportPublic FDA data

SFS

Primary DI
18257200061129
Brand
SFS
Company
Orthofix US LLC
Model
61-8355
Device description
4.0MM X 55MM MONO-AXIAL REDUCTION SCREW, STD
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIOrthosis, spinal pedicle fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080407000BLACKSTONE SFS PARALLEL ROD CONNECTORSBlackstone Medical, Inc.2008-03-13MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200061129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720006112918257200061129

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200028177PHOENIX SFS20-01012026-07-17
18257200028207PHOENIX SFS20-01202026-07-17
18257200028917FIREBIRD SFS201130732026-07-17
18257200028924FIREBIRD SFS201130742026-07-17
18257200028931FIREBIRD SFS201130752026-07-17
18257200028948FIREBIRD SFS201130762026-07-17
18257200028955FIREBIRD SFS201130782026-07-17
18257200028979FIREBIRD SFS201130802026-07-17
18257200028986FIREBIRD SFS201130812026-07-17
18257200028993FIREBIRD SFS201130822026-07-17
18257200029006FIREBIRD SFS201130832026-07-17
18257200029013FIREBIRD SFS201130842026-07-17
18257200029020FIREBIRD SFS201130852026-07-17
18257200029280FIREBIRD SFS201147972026-07-17
18257200029846FIREBIRD SFS301100252026-07-17
18257200029853FIREBIRD SFS301100262026-07-17
18257200029860FIREBIRD SFS301100272026-07-17
18257200029877FIREBIRD SFS301100282026-07-17
18257200029884FIREBIRD SFS301100292026-07-17
18257200029945FIREBIRD SFS301100352026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
04546540147257XIA IIStryker CorporationMNI2014-12-08
04546540147769XIA IIStryker CorporationMNI2014-12-08
04546540147806XIA IIStryker CorporationMNI2014-12-08
04546540147905XIA IIStryker CorporationMNI2014-12-08
04546540147912XIA IStryker CorporationMNI2014-12-08
04546540147929XIA IStryker CorporationMNI2014-12-08
04546540147936XIA IStryker CorporationMNI2014-12-08
04546540147974XIA IStryker CorporationMNI2014-12-08
04546540147981XIA IStryker CorporationMNI2014-12-08
04546540147998XIA IStryker CorporationMNI2014-12-08
04546540148001XIA IIStryker CorporationMNI2014-12-08
04546540148018XIA IIStryker CorporationMNI2014-12-08
04546540148025XIA IIStryker CorporationMNI2014-12-08
04546540148735XIA IIStryker CorporationMNI2014-12-08
04546540148742XIA IIStryker CorporationMNI2014-12-08
04546540148759XIA IIStryker CorporationMNI2014-12-08
04546540148766XIA IIStryker CorporationMNI2014-12-08
04546540148773XIA IIStryker CorporationMNI2014-12-08
04546540148780XIA IIStryker CorporationMNI2014-12-08
04546540148797XIA IIStryker CorporationMNI2014-12-08
04546540148803XIA IIStryker CorporationMNI2014-12-08
04546540148810XIA IIStryker CorporationMNI2014-12-08
04546540148827XIA IIStryker CorporationMNI2014-12-08
04546540148834XIA IIStryker CorporationMNI2014-12-08
04546540148841XIA IIStryker CorporationMNI2014-12-08