FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
K Number: K260340
·
Decision Apr 13, 2026
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
2
Review Days
70
Basic Information
- Device Name
- HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
- K Number
- K260340
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HC Biologics, LLC
- Date Received
- February 2, 2026
- Decision Date
- April 13, 2026
- 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
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by HC Biologics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K250092 | HC Biologics Osteopoint Spinal Fixation System | Mar 27, 2025 | Substantially Equivalent |