FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMC 28MM CERAMIC FEMORAL HEADS
K Number: K981302
·
Decision Jun 25, 1998
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
9
Review Days
77
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Basic Information
- Device Name
- SMC 28MM CERAMIC FEMORAL HEADS
- K Number
- K981302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signal Medical Corp.
- Date Received
- April 9, 1998
- Decision Date
- June 25, 1998
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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| 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 |
| K971681 | SMC FEMORAL HIP COMPONENT | Dec 4, 1997 | Substantially Equivalent |
| K971018 | SMC ACETABULAR COMPONENT | Oct 24, 1997 | Substantially Equivalent |