FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENOVIS BIPOLAR HIP SYSTEM
K Number: K131354
·
Decision Sep 19, 2013
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
9
Review Days
132
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Basic Information
- Device Name
- RENOVIS BIPOLAR HIP SYSTEM
- K Number
- K131354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovis Surgical Technologies, LLC
- Date Received
- May 10, 2013
- Decision Date
- September 19, 2013
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 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 |
| K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | May 11, 2011 | Substantially Equivalent |
| K101682 | S 100 PEDICLE SCREW SYSTEM | Dec 7, 2010 | Substantially Equivalent |