Whistler Modular Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name: Whistler Modular Pedicle Screw System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: DIA 7.5 x 35mm, Solid, HA FDA UDI
Model / Reference: WS7535-H FDA UDI
Description: DIA 7.5 x 35mm, Solid, HA FDA UDI

Identifiers

Catalog Number: WS7535-H FDA UDI
Primary DI / UDI-DI: 00195860003732 FDA UDI
510(k) Number: K182478 FDA UDI
FDA Product Code: NKB 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 7.5 Millimeter FDA UDI
Length — 35 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

The Whistler Modular Pedicle Screw System (MPS) is a non-surgical, minimally invasive spinal fixation device designed to provide stabilization and immobilization of spinal segments in the treatment of spinal instabilities or deformities. It consists of a small, threaded implantable rod with a screw head and drive, made from a non-chemically degraded material that is not absorbed via natural body processes.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

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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

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: Evolution Spine, Llc

Sources (1)

FDA UDI 3f73fb54-af4f-49f2-a744-d06572984ac0 37 fields · synced Jul 20, 2026

Whistler Modular Pedicle Screw System

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)