Pls

FDA UDI

Class II (US FDA UDI)

by Boxspine Holdings, Inc.

Identity

Trade Name: PLS FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Ø5.5 Polyaxial Pedicle Screw Non-Cannulated with Screw Cap Ø7.5 x 40mm (Violet) FDA UDI
Model / Reference: 06.6394B-K FDA UDI
Description: Ø5.5 Polyaxial Pedicle Screw Non-Cannulated with Screw Cap Ø7.5 x 40mm (Violet) FDA UDI

Identifiers

Catalog Number: 06.6394B-K FDA UDI
Primary DI / UDI-DI: G463066394BK0 FDA UDI
FDA Product Code: KWP FDA UDI
NKB FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
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

Category: Spinal bone screw, non-bioabsorbable

Pls by Boxspine Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spinal bone screw, non-bioabsorbable.

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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: Boxspine Holdings, Inc.

Sources (1)

FDA UDI 938ff3c5-26e8-43f2-a18a-1b691fa45bf0 34 fields · synced Jun 1, 2026