Identity
- Trade Name
- Pulsar Expandable PLIF System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- The Pulsar Expandable PLIF Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The Pulsar Expandable PLIF Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI). The Pulsar Expandable PLIF Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. The Expandable PLIF Cage (Posterior Lumbar Interbody Fusion Cage) are designed for segments L2 to S1. FDA UDI
- Model / Reference
- 2210-1180 FDA UDI
- Description
- The Pulsar Expandable PLIF Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The Pulsar Expandable PLIF Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI). The Pulsar Expandable PLIF Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. The Expandable PLIF Cage (Posterior Lumbar Interbody Fusion Cage) are designed for segments L2 to S1. FDA UDI
Identifiers
- Catalog Number
- 2210-1180 FDA UDI
- Primary DI / UDI-DI
- 08800104089701 FDA UDI
- 510(k) Number
- K221687 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Polymeric spinal interbody fusion cage
Pulsar Expandable PLIF System by GS Medical Co., Ltd. — 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
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- 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
K221687 also covers:
- AnyPlus Spinal Fixation System — GS Medical Co., Ltd.
- AnyPlus Spinal Fixation System — GS Medical Co., Ltd.
- Anyplus II Spinal Fixation System — GS Medical Co., Ltd.
- Anyplus II Spinal Fixation System — GS Medical Co., Ltd.
- PYXIS 3D Titanium Cervical Cage System — GS Medical Co., Ltd.
- PYXIS 3D Titanium Cervical Cage System — GS Medical Co., Ltd.
- PYXIS 3D Titanium Cervical Cage System — GS Medical Co., Ltd.
- PYXIS 3D Titanium Cervical Cage System — GS Medical Co., Ltd.
- PYXIS 3D Titanium Cervical Cage System — GS Medical Co., Ltd.
- PYXIS 3D Titanium X-TLIF Cage, Open — GS Medical Co., Ltd.
- PYXIS 3D Titanium X-TLIF Cage, Open — GS Medical Co., Ltd.
- PYXIS 3D Titanium X-TLIF Cage, Open — GS Medical Co., Ltd.
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
- GS Medical Co., Ltd.
Sources (1)
- FDA UDI 664bf62f-b845-4cc8-a002-25ed614eda81 36 fields · synced May 30, 2026