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Swedge Pedicle Screw Fixation System

FDA UDI

Class II (US FDA UDI)

by Spinal Resources Inc

Identity

Trade Name
Swedge Pedicle Screw Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Rod, STANDARD, Transition, Titanium, Straight, x 400mm FDA UDI
Model / Reference
RSTT-400 FDA UDI
Description
Rod, STANDARD, Transition, Titanium, Straight, x 400mm FDA UDI

Identifiers

Primary DI / UDI-DI
B515RSTT4000 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system connector

Swedge Pedicle Screw Fixation System by Spinal Resources Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Resources Inc

Sources (1)

  • FDA UDI 8c333f40-5eaa-40a4-a17a-6655e98a883f 33 fields · synced Jun 8, 2026