FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ShurFit CpTi-HA ACIF Interbody Fusion System
K Number: K161809
·
Decision Dec 6, 2016
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
24
Review Days
158
Basic Information
- Device Name
- ShurFit CpTi-HA ACIF Interbody Fusion System
- K Number
- K161809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Spine, Inc.
- Date Received
- July 1, 2016
- Decision Date
- December 6, 2016
- 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 Precision Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250769 | Dakota LP System | Nov 24, 2025 | Substantially Equivalent |
| K242297 | Reform Pedicle Screw System | Dec 17, 2024 | Substantially Equivalent |
| K231229 | S-COMP Reform® POCT Navigation Instruments | May 25, 2023 | Substantially Equivalent |
| K220862 | E-GPS Navigated Instruments | Jul 14, 2022 | Substantially Equivalent |
| K213118 | Dakota ALIF System | Apr 1, 2022 | Substantially Equivalent |
| K220324 | AccuFit Lateral 2-Hole Plate | Mar 16, 2022 | Substantially Equivalent |
| K212075 | ShurFit Lumbar Interbody System | Dec 8, 2021 | Substantially Equivalent |
| K212937 | Dakota ALIF Plate System | Nov 4, 2021 | Substantially Equivalent |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Jan 12, 2021 | Substantially Equivalent |
| K181606 | Precision Spine Navigation Instrumentation | Sep 27, 2019 | Substantially Equivalent |