Identity
- Trade Name
- Peridot Intervertebral body fusion system FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Model / Reference
- L331-8198 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800044792181 FDA UDI
- 510(k) Number
- K192026 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
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 Intervertebral body fusion system by GBS Commonwealth Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polymeric spinal interbody fusion cage.
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Cleared under the same submission
K192026 also covers:
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd.
- Peridot 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 bbb2bde7-b427-4d29-b59d-079df8e1fd2d 33 fields · synced May 30, 2026