FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
K Number: K033242
·
Decision Dec 31, 2003
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
- K Number
- K033242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3590
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Therapeutics, Inc.
- Date Received
- October 7, 2003
- Decision Date
- December 31, 2003
- Product Code
- HSH
- 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 |
|---|---|---|---|
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSH), ordered by most recent decision date.
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
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ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
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OTI UNICONDULAR INTERPOSITIONAL SPACER
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UNICONDYLAR INTERPOSITIONAL SPACER
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Other Clearances by Imaging Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082402 | OSDX HIP BMD SYSTEM | Oct 16, 2008 | Substantially Equivalent |