FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINAL USA INTERBODY CAGES
K Number: K092193
·
Decision Sep 25, 2009
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
23
Review Days
66
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPINAL USA INTERBODY CAGES
- K Number
- K092193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal USA
- Date Received
- July 21, 2009
- Decision Date
- September 25, 2009
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Spinal USA
| K Number | Device Name | ||
|---|---|---|---|
| K132029 | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE | Nov 25, 2013 | Substantially Equivalent |
| K130863 | FACET SCREW SYSTEM | Aug 9, 2013 | Substantially Equivalent |
| K131343 | REFORM PEDICLE SCREW SYSTEM | Jul 24, 2013 | Substantially Equivalent |
| K130279 | REFORM PEDICLE SCREW SYSTEM | Jun 20, 2013 | Substantially Equivalent |
| K130445 | VAULT ALIF SYSTEM | Apr 25, 2013 | Substantially Equivalent |
| K122931 | S-LOK PSS SYSTEM | Nov 20, 2012 | Substantially Equivalent |
| K121172 | REFORM PEDICLE SCREW SYSTEM | Aug 8, 2012 | Substantially Equivalent |
| K112025 | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM | Sep 15, 2011 | Substantially Equivalent |
| K103369 | VAULT ALIF SYSTEM | Apr 4, 2011 | Substantially Equivalent |
| K092659 | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 | Nov 17, 2009 | Substantially Equivalent |