Streamline TL Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Streamline TL Spinal Fixation System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: REDUCTION SCREW FDA UDI
Model / Reference: 01-RS-85-95 FDA UDI
Description: REDUCTION SCREW FDA UDI

Identifiers

Catalog Number: 01-RS-85-95 FDA UDI
Primary DI / UDI-DI: 00846468057084 FDA UDI
FDA Product Code: KWQ FDA UDI
MNI FDA UDI
NKB FDA UDI
MNH FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3070 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Streamline TL Spinal Fixation System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 2fca204b-ba60-4bb6-9558-15c9a56bbdd3 37 fields · synced May 31, 2026