Blustone Synergy Lumbar Interbody Fusion System (Basalt)

FDA UDI

Class II (US FDA UDI)

by Blustone Synergy

Identity

Trade Name: Blustone Synergy Lumbar Interbody Fusion System (Basalt) FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; or - as a single device via a transverse (T-PLIF) approach. FDA UDI
Model / Reference: 2410-PL13 FDA UDI
Description: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; or - as a single device via a transverse (T-PLIF) approach. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810482030408 FDA UDI
510(k) Number: K171893 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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: Height — 13 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI
Length — 24 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

Blustone Synergy Lumbar Interbody Fusion System (Basalt) by Blustone Synergy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K171893 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 c1c09e5a-5a41-4861-a8e5-ff209603629e 36 fields · synced May 30, 2026