gudid
Primary ID: 55-PM-3532
Reform POCT System (UDI 55-PM-3532)
Manufactured by PRECISION SPINE, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Reform POCT System - Primary ID 55-PM-3532
Device Regulatory Overview
The Reform POCT System (Model/Catalog Number: 55-PM-3532) is a medical device manufactured by PRECISION SPINE, INC.. This product is indexed under FDA Product Code / Category Classification NKG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 55-PM-3532
- Product Code / EMDN
- NKG
- Device Name
- 3.5 x 32mm Polyaxial Screw - M/L Bias
- Database Sync Date
- 2026-08-09 09:33:11
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Reform POCT System?
The registered manufacturer of record for Reform POCT System is PRECISION SPINE, INC..
What is the Primary UDI-DI identifier for Reform POCT System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 55-PM-3532.
What classification code is assigned to this device?
This device is registered under product classification code NKG.
Similar Classification Devices (NKG)
Other Devices by PRECISION SPINE, INC.
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