Blustone Synergy Lumbar Shaver - Magma

FDA UDI

Class I (US FDA UDI)

by Blustone Synergy

Identity

Trade Name: Blustone Synergy Lumbar Shaver (Basalt, Obsidian, Magma) FDA UDI
Generic Name: Orthopaedic chisel FDA UDI
Device Name: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The lumbar shavers are available in sizes between 7mm and 15mm. FDA UDI
Model / Reference: 9001-SH09 FDA UDI
Description: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The lumbar shavers are available in sizes between 7mm and 15mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810482030798 FDA UDI
FDA Product Code: HTZ FDA UDI
GMDN Term: Orthopaedic chisel FDA UDI
Models / Variants: Basalt FDA UDI
Obsidian FDA UDI
Magma FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 9 Millimeter FDA UDI

Category: Orthopaedic chisel

Blustone Synergy Lumbar Shaver - Magma by Blustone Synergy — Class I — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Blustone Synergy

Sources (1)

FDA UDI ba76f362-01f2-4782-8b3b-4dc322461195 35 fields · synced Jun 8, 2026