FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
K Number: K132312
·
Decision Apr 11, 2014
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
9
Review Days
260
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Basic Information
- Device Name
- RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
- K Number
- K132312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovis Surgical Technologies, LLC
- Date Received
- July 25, 2013
- Decision Date
- April 11, 2014
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Renovis Surgical Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Sep 19, 2013 | 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 |
| K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | May 11, 2011 | Substantially Equivalent |
| K101682 | S 100 PEDICLE SCREW SYSTEM | Dec 7, 2010 | Substantially Equivalent |