FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
K Number: K110965
·
Decision May 11, 2011
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
8
Review Days
35
Basic Information
- Device Name
- RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
- K Number
- K110965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RENOVIS SURGICAL TECHNOLOGIES, LLC
- Date Received
- April 6, 2011
- Decision Date
- May 11, 2011
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by RENOVIS SURGICAL TECHNOLOGIES, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM | Apr 11, 2014 | Substantially Equivalent |
| K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Sep 18, 2013 | Substantially Equivalent |
| K120038 | A200 KNEE SYSTEM | Feb 14, 2013 | Substantially Equivalent |
| K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | Jun 13, 2012 | Substantially Equivalent |
| K111940 | S 100 PEDICLE SCREW SYSTEM | May 15, 2012 | Substantially Equivalent |
| K113084 | RENOVIS CANNULATED SCREW SYSTEM | Dec 9, 2011 | Substantially Equivalent |
| K101682 | S 100 PEDICLE SCREW SYSTEM | Dec 7, 2010 | Substantially Equivalent |