FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYMMETRIC TOTAL KNEE AGUMENTS
K Number: K100370
·
Decision Mar 7, 2011
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
9
Review Days
388
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Basic Information
- Device Name
- SYMMETRIC TOTAL KNEE AGUMENTS
- K Number
- K100370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signal Medical Corp.
- Date Received
- February 12, 2010
- Decision Date
- March 7, 2011
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Signal Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) | Mar 24, 2008 | Substantially Equivalent |
| K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM | Mar 22, 2006 | Substantially Equivalent |
| K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT | Feb 11, 2005 | Substantially Equivalent |
| K022382 | RHS ACETABULAR COMPONENT | Oct 4, 2002 | Substantially Equivalent |
| K021063 | GREAT TOE IMPLANT | Jul 1, 2002 | Substantially Equivalent |
| K981302 | SMC 28MM CERAMIC FEMORAL HEADS | Jun 25, 1998 | Substantially Equivalent |
| K971681 | SMC FEMORAL HIP COMPONENT | Dec 4, 1997 | Substantially Equivalent |
| K971018 | SMC ACETABULAR COMPONENT | Oct 24, 1997 | Substantially Equivalent |