FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K Number: K042899
·
Decision Mar 16, 2005
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
13
Applicant Total
402
Review Days
147
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Basic Information
- Device Name
- SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
- K Number
- K042899
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- October 20, 2004
- Decision Date
- March 16, 2005
- Product Code
- HTO
- 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 |
|---|---|---|---|
| HTO | Reamer | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTO), ordered by most recent decision date.
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
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COMBINATION REAMER
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MCCONNELL REAMER GUIDE
FDA 510(k)
FDA Class 1
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| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Jan 21, 2011 | Substantially Equivalent |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
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| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 3, 2010 | Substantially Equivalent |