Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif

FDA UDI

Class II (US FDA UDI)

by Bm Korea Co., Ltd

Identity

Trade Name: SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Device Name: The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. FDA UDI
Model / Reference: SPT0832 FDA UDI
Description: The SYNSTER CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809255541090 FDA UDI
510(k) Number: K122518 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 32 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI

Category: Metallic spinal fusion cage, non-sterile

Synster (cervical, Alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif by Bm Korea Co., Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Metallic spinal fusion cage, non-sterile.

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PLIF Cage — Eisertech, LLC · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Copperhead — EMINENT SPINE LLC · Class II
SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II

Cleared under the same submission

K122518 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: Bm Korea Co., Ltd

Sources (1)

FDA UDI fcd979a0-f5a9-4055-ad38-224b8809e0a0 35 fields · synced Jun 8, 2026