BandLoc DUO 10-1102-1555

GUDID 00841132150627

BandLoc DUO 5.5/6.0 Sterile Implant

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132150627
• NIH Device Record Key: 94900513-3db2-42a8-8134-307ce9f1339a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BandLoc DUO
• Version Model Number: 10-1102-1555
• Catalog Number: 10-1102-1555
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132150627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161267

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-18
• Device Publish Date: 2020-02-10

Devices Manufactured by ORTHOPEDIATRICS CORP.

• 00841132185179 - Response 4.5/5.0, Response 5.5/6.0: 2024-10-25 Rod Template Trial 3.2mm Nitinol Rod Silicone Sleeve 500mm Length Blue
• 00841132185186 - Response 4.5/5.0, Response 5.5/6.0: 2024-10-25 Rod Template Trial 5mm Nitinol Rod Silicone Sleeve 500mm Length Black
• 00840194493918 - Response 5.5, Response 5.5/6.0: 2024-10-03 Extended Mini-Reducer Long Handle
• 00840194467094 - PNP TIBIA: 2024-09-19 NITINOL FLEX SHAFT, 435mm
• 00840194467100 - PNP TIBIA: 2024-09-19 NITINOL FLEX SHAFT, 635mm
• 00840194467117 - PNP TIBIA: 2024-09-19 6.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467124 - PNP TIBIA: 2024-09-19 6.5mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467131 - PNP TIBIA: 2024-09-19 7.0mm MONOBLOC NITINOL REAMER, 435mm