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Peridot Anterior Cervical Intervertebral Body Fusion System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Peridot Anterior Cervical Intervertebral Body Fusion System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Model / Reference
- C213-1410 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800113301603 FDA UDI
- 510(k) Number
- K202872 FDA UDI
- FDA Product Code
- ODP 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
No
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
Peridot Anterior Cervical Intervertebral Body Fusion System by GBS Commonwealth Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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
- 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
- CEZANNE — CTL Medical Corporation · Class II
Cleared under the same submission
K202872 also covers:
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth Co., Ltd.
- Peridot Anterior Cervical Intervertebral Body Fusion System — GBS Commonwealth 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
- GBS Commonwealth Co., Ltd.
Sources (1)
- FDA UDI 31ac010b-b8cf-4710-bd25-87d9726944c9 33 fields · synced Jun 8, 2026