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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
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Screw Tap, Standard, Cannulated, 8.5 x 30mm long FDA UDI
Model / Reference
2-106-85 FDA UDI
Description
Screw Tap, Standard, Cannulated, 8.5 x 30mm long FDA UDI

Identifiers

Primary DI / UDI-DI
B5152106850 FDA UDI
510(k) Number
K170045 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

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: General internal orthopaedic fixation system implantation kit

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 General internal orthopaedic fixation system implantation kit.

Cleared under the same submission

K170045 also covers:

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 cecb165b-28ba-4354-92b6-d05b6646e247 34 fields · synced May 30, 2026