BandLoc 10-1102-0555

GUDID 00841132124413

BandLoc 5.5/6.0 Sterile Implant

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132124413
• NIH Device Record Key: 7938a2ef-fdbb-4b09-baca-9193d9c7d59f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BandLoc
• Version Model Number: 10-1102-0555
• Catalog Number: 10-1102-0555
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132124413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161267

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00841132124413]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-20

On-Brand Devices [BandLoc]

• 00841132137956: BANDLOC MINI LRG SET SCREW CADDY LID
• 00841132137161: BANDLOC CASE LID
• 00841132136003: BANDLOC CASE LID
• 00841132135990: LARGE SET SCREW CADDY
• 00841132135914: BANDLOC STERILE IMPLANT
• 00841132128817: DEPTH GAUGE 10-100MM
• 00841132128800: OrthoPediatrics BandLoc Case Caddy Lid
• 00841132124413: BandLoc 5.5/6.0 Sterile Implant
• 00841132144039: BANDLOC IMPLANT & INSTRUMENT
• 00841132138427: BANDLOC MINI LID