FDA.reportPublic FDA data

BandLoc DUO

Primary DI
00841132150627
Brand
BandLoc DUO
Company
ORTHOPEDIATRICS CORP.
Model
10-1102-1555
Catalog number
10-1102-1555
Device description
BandLoc DUO 5.5/6.0 Sterile Implant
Published
2020-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K161267000
K200097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161267000Response BandLoc Spinal FixationOrthoPediatrics Corp.2016-08-11OWI
K200097000Response BandLoc Spinal FixationOrthoPediatrics Corp.2020-03-16OWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132150627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132150627008411321506278411321506270841132150627

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008405368000393P Hip System01-3002-101301-3002-10132026-06-09
008405368000463P Hip System01-3002-201301-3002-20132026-06-09
008405368000533P Hip System01-3002-301301-3002-30132026-06-09
008405368000603P Hip System01-3035-005001-3035-00502026-06-09
00840536822741Response 5.5/6.001-1300-653501-1300-65352026-05-30
00840536822758Response 5.5/6.001-1300-653601-1300-65362026-05-30
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13

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
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00193982506513HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506520HILINEGLOBUS MEDICAL, INC.OWI2024-07-22