FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
K Number: K233839
·
Decision Dec 20, 2023
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
14
Review Days
16
Basic Information
- Device Name
- Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
- K Number
- K233839
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gbs Commonwealth Co., Ltd.
- Date Received
- December 4, 2023
- Decision Date
- December 20, 2023
- Product Code
- ODP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Gbs Commonwealth Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Nov 21, 2023 | Substantially Equivalent |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Nov 7, 2023 | Substantially Equivalent |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Oct 13, 2023 | Substantially Equivalent |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | May 22, 2023 | Substantially Equivalent |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Feb 17, 2023 | Substantially Equivalent |
| K213980 | Peridot Spinal Interbody System | Mar 15, 2022 | Substantially Equivalent |
| K211205 | Prase-C Anterior Cervical Plate System | Aug 12, 2021 | Substantially Equivalent |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Feb 4, 2021 | Substantially Equivalent |
| K202878 | Prase-AP Anterior Cervical Plate System | Jan 29, 2021 | Substantially Equivalent |
| K192026 | Peridot Intervertebral body fusion System | Nov 26, 2019 | Substantially Equivalent |