FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES SYNMESH
K Number: K983766
·
Decision Dec 18, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
11
Applicant Total
402
Review Days
53
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Basic Information
- Device Name
- SYNTHES SYNMESH
- K Number
- K983766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- October 26, 1998
- Decision Date
- December 18, 1998
- Product Code
- EZX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| EZX | Mesh, Surgical, Metal | FDA class 2 | General, Plastic Surgery |
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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 |