FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SPINAL USA VBR SYSTEM
K Number: K070922
·
Decision Sep 19, 2007
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
23
Review Days
170
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Basic Information
- Device Name
- MODIFICATION TO SPINAL USA VBR SYSTEM
- K Number
- K070922
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal USA
- Date Received
- April 2, 2007
- Decision Date
- September 19, 2007
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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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 |