FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
F3D Interbody System
K Number: K230329
·
Decision Jun 6, 2023
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
35
Review Days
120
Basic Information
- Device Name
- F3D Interbody System
- K Number
- K230329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corelink, LLC
- Date Received
- February 6, 2023
- Decision Date
- June 6, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Corelink, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Dec 8, 2023 | Substantially Equivalent |
| K231494 | CoreLink Robotic Navigation Instruments | Oct 27, 2023 | Substantially Equivalent |
| K232116 | CoreLink Navigation Instruments | Aug 16, 2023 | Substantially Equivalent |
| K230880 | CoreLink Navigation Instruments | May 2, 2023 | Substantially Equivalent |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Mar 21, 2023 | Substantially Equivalent |
| K221776 | NextGen Pedicle Screw System | Aug 9, 2022 | Substantially Equivalent |
| K220973 | CoreLink Navigation Instruments | Jun 1, 2022 | Substantially Equivalent |
| K211417 | F3D-C2 Cervical Stand-Alone System | Feb 4, 2022 | Substantially Equivalent |
| K214059 | CoreLink Navigation Instruments | Jan 19, 2022 | Substantially Equivalent |
| K212825 | CoreLink Navigation Instruments | Oct 13, 2021 | Substantially Equivalent |