FDA.reportPublic FDA data

SILC

Primary DI
00889095230253
Brand
SILC
Company
GLOBUS MEDICAL, INC.
Model
1116.0006S
Device description
SILC 6.0mm Band, 550mm
Published
2015-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWIBone fixation cerclage, sublaminar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWIBone Fixation Cerclage, SublaminarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133482000SILC FIXATION SYSTEMGlobus Medical, Inc.2014-05-21OWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095230253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095230253008890952302538890952302530889095230253

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length550Millimeter
Width6Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376696140InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376696157InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721699InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721705InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721712InvictusALPHATEC SPINE, INC.OWI2026-04-09
00763000881696TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-02-05
00763000881702TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-02-05
00840085278518ALTAAstura MedicalOWI2026-02-03
00840085277603ALTAAstura MedicalOWI2026-02-02
00840085278051ALTAAstura MedicalOWI2026-02-02
00840085278068ALTAAstura MedicalOWI2026-02-02
10888857581852NILE™ Alternative Fixation SystemVB Spine LLCOWI2025-03-21
00887517721518VersaTieNuvasive, Inc.OWI2024-11-27
00763000675035TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2024-11-04
00193982506216HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506223HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506230HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506247HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506254HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506261HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506278HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506285HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506292HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506445HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506452HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506469HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506476HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506490HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506513HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506520HILINEGLOBUS MEDICAL, INC.OWI2024-07-22