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Streamline™* Tl Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
STREAMLINE™* TL SPINAL FIXATION SYSTEM FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
PEDICLE SCREW, FIXED FDA UDI
Model / Reference
01-FX-55-50 FDA UDI
Description
PEDICLE SCREW, FIXED FDA UDI

Identifiers

Catalog Number
01-FX-55-50 FDA UDI
Primary DI / UDI-DI
00846468053123 FDA UDI
FDA Product Code
KWQ FDA UDI
MNH FDA UDI
MNI FDA UDI
NKB 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Streamline™* Tl Spinal Fixation System by Pioneer Surgical Technology, 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

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI ded7563c-c346-4f93-8b9d-a99e5e5c17c2 36 fields · synced May 31, 2026