FDA.reportPublic FDA data

SFS;SFS LE;SFS SCOLI

Primary DI
18257200058556
Brand
SFS;SFS LE;SFS SCOLI
Company
Orthofix US LLC
Model
59-4755
Device description
7.5X55 MONO-AXIAL REDUCTION PEDICLE SCREW
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
18257200058556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720005855618257200058556

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
18257200115112Collage7100052016-03-02
18257200115129Collage7100102016-03-02
18257200115136Collage7100152016-03-02
18257200121861Collage7110102016-09-14
18257200121878Collage7110152016-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B06210018530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210038590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210048530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B062100100000JBlack Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-02-14
B06210022070Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-01-13
B06210022075Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-01-13