Pediatric Patient Positioner

GUDID 00190376603438

T-HANDLE, LATERAL ARM

ALPHATEC SPINE, INC.

Operating table orthopaedic extension, non-powered

• Primary Device ID: 00190376603438
• NIH Device Record Key: 0dd5f287-f588-47a6-9f90-7dab435ce559
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Patient Positioner
• Version Model Number: 551-160
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376603438 [Primary]

FDA Product Code

• CCX: SUPPORT, PATIENT POSITION

Sterilization

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

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

[00190376603438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [Pediatric Patient Positioner]

• 00190376654959: Pediatric Patient Positioner Disposable Kit
• 00190376603568: Pelvic Base, Thin Pad
• 00190376603551: Pelvic Base, Thick Pad
• 00190376603544: Pelvic Lateral, Small Pad
• 00190376603537: Pelvic Lateral, Large Pad
• 00190376603520: Thoracic Lateral, Small Pad
• 00190376603513: Thoracic Lateral, Large Pad
• 00190376603506: Thoracic Base, Right Pad
• 00190376603490: Thoracic Base, Left Pad
• 00190376603483: Thoracic Sizer, Non-Centering, XL
• 00190376603476: Thoracic Sizer, Non-Centering, L
• 00190376603469: Thoracic Sizer, Non-Centering, M
• 00190376603452: Thoracic Sizer, Non-Centering, S
• 00190376603445: Thoracic Sizer, Non-Centering, XS
• 00190376596433: Pelvic Handle L
• 00190376596426: Pelvic Handle R
• 00190376596402: Mirror
• 00190376596396: Sagittal Handle
• 00190376596389: Head Support, Plate
• 00190376596372: Head Support
• 00190376596365: Pelvic Sizer, XL
• 00190376596358: Pelvic Sizer, L
• 00190376596341: Pelvic Sizer, M
• 00190376596334: Pelvic Sizer, S
• 00190376596327: Pelvic Sizer, XS
• 00190376596310: Thoracic Sizer, XL
• 00190376596303: Thoracic Sizer, L
• 00190376596297: Thoracic Sizer, M
• 00190376596280: Thoracic Sizer, S
• 00190376596273: Thoracic Sizer, XS
• 00190376596266: Pelvic Paddle, 90 Degree
• 00190376596259: Pelvic Paddle, 45 Degree
• 00190376596242: Pelvic Paddle, 0 Degree
• 00190376596235: Pelvic Paddle, Small L
• 00190376596228: Pelvic Paddle, Small R
• 00190376596211: Pelvic Paddle, Large L
• 00190376596204: Pelvic Paddle, Large R
• 00190376596198: Thoracic Paddle, Extended L
• 00190376596181: Thoracic Paddle, Extended R
• 00190376596174: Thoracic Paddle, Standard L
• 00190376596167: Thoracic Paddle, Standard R
• 00190376596150: Thoracic Paddle, Small L
• 00190376596143: Thoracic Paddle, Small R
• 00190376596136: Thoracic Paddle, Large L
• 00190376596129: Thoracic Paddle, Large R
• 00190376596112: Pelvic Lateral Carriage Assembly
• 00190376596105: Pelvic Positioner
• 00190376596099: A-Arm Thoracic Lateral Carriage Assembly
• 00190376596082: Thoracic Anterior Plate L
• 00190376596075: Thoracic Anterior Plate R