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Lordotic Trial Sizer with Stop 20x12, H11mm

FDA UDI

Class I (US FDA UDI)

by Spineup, Inc.

Identity

Trade Name
Lordotic Trial Sizer with Stop 20x12, H11mm FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Lordotic Trial Sizer with Stop 20x12, H11mm FDA UDI
Model / Reference
RO0597LG1120X12 FDA UDI
Description
Lordotic Trial Sizer with Stop 20x12, H11mm FDA UDI

Identifiers

Catalog Number
RO0597LG1120X12 FDA UDI
Primary DI / UDI-DI
B806RO0597LG1120X120 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Lordotic Trial Sizer with Stop 20x12, H11mm by Spineup, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineup, Inc.

Sources (1)

  • FDA UDI 9d3da0a2-72c4-467d-a598-18a75ccd8e89 35 fields · synced Jun 6, 2026