Silverbolt/Mainframe

FDA UDI

Class II (US FDA UDI)

by Choicespine, LP

Identity

Trade Name: Silverbolt/Mainframe FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: SILVERBOLT,SCREW,POLYAXIAL,6.5X80 FDA UDI
Model / Reference: 200-2280 FDA UDI
Description: SILVERBOLT,SCREW,POLYAXIAL,6.5X80 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840996170192 FDA UDI
510(k) Number: K062670 FDA UDI
FDA Product Code: MNH FDA UDI
NKB FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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

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

Dimensions & Sizes

Size: Outer Diameter — 6.5 Millimeter FDA UDI
Length — 80 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Welcome to our directory of medical devices, specifically the Silverbolt/Mainframe. This implantable rod with a screw head and drive is designed for internal spinal fixation by stabilizing and immobilizing spinal segments in patients undergoing treatment for spinal instabilities or deformities.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

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LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

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: Choicespine, LP

Sources (1)

FDA UDI f59477ad-1f3d-4a44-b05e-ac6e97ad3f59 36 fields · synced Jul 25, 2026