Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)

FDA UDI

Class II (US FDA UDI)

by Blustone Synergy

Identity

Trade Name: Blustone Synergy Spinal Intervertebral Body Fixation System (Silica) FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The implants are designed with a 15mm x 13mm footprint in heights ranging from 20 to 50mm in three (3) mm increments. The device is hollow to allow for placement of autograft and/or allogenic bone graft and facilitate fusion, and contains tantalum markers to assist the surgeon with proper placement of the device. The device may be implanted as a single device via an anterior approach. FDA UDI
Model / Reference: 1513-C350 FDA UDI
Description: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The implants are designed with a 15mm x 13mm footprint in heights ranging from 20 to 50mm in three (3) mm increments. The device is hollow to allow for placement of autograft and/or allogenic bone graft and facilitate fusion, and contains tantalum markers to assist the surgeon with proper placement of the device. The device may be implanted as a single device via an anterior approach. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810482030293 FDA UDI
510(k) Number: K172330 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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: Width — 13 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI
Height — 50 Millimeter FDA UDI

Category: Vertebral body prosthesis

Blustone Synergy Spinal Intervertebral Body Fixation System (Silica) by Blustone Synergy — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Vertebral body prosthesis.

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Cleared under the same submission

K172330 also covers:

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: Blustone Synergy

Sources (1)

FDA UDI 6e025c7d-0e4f-4ca9-9d50-6104775f7272 36 fields · synced May 30, 2026