Periacetabular Osteotomy System 01-1401-0002

GUDID 00841132128725

OFFSET CURVED OSTEOTOME, RIGHT

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132128725
• NIH Device Record Key: f3aaf29c-8c17-448b-9308-3fb5dc0f5ce2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Periacetabular Osteotomy System
• Version Model Number: 01-1401-0002
• Catalog Number: 01-1401-0002
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132128725 [Primary]

FDA Product Code

• HWM: OSTEOTOME

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-31

On-Brand Devices [Periacetabular Osteotomy System]

• 00841132128756: PAO TRAY LID
• 00841132128749: PAO TRAY
• 00841132128732: DUAL-SPIKED PUBIS RETRACTOR
• 00841132128725: OFFSET CURVED OSTEOTOME, RIGHT
• 00841132128718: OFFSET CURVED OSTEOTOME, LEFT
• 00840194478502: Single Point Offset Pubis Retractor
• 00840194478403: PAO Special Pubis Retractor