FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPORTMESH
K Number: K052830
·
Decision Jan 19, 2006
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
7
Review Days
106
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Basic Information
- Device Name
- SPORTMESH
- K Number
- K052830
- 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
- Artimplant AB
- Date Received
- October 5, 2005
- Decision Date
- January 19, 2006
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Artimplant AB
| K Number | Device Name | ||
|---|---|---|---|
| K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | Sep 18, 2007 | Substantially Equivalent |
| K061956 | ARTELON STT SPACER | Jun 7, 2007 | Substantially Equivalent |
| K061954 | ARTELON CMC SPACER ARTHRO | Jun 1, 2007 | Substantially Equivalent |
| K052482 | ARTELON SURGICAL SUTURE | Oct 17, 2005 | Substantially Equivalent |
| K040070 | ARTELON SPACER CMC-1 | Sep 21, 2004 | Substantially Equivalent |
| K032160 | ARTELON SURGICAL SUTURE | Nov 17, 2003 | Substantially Equivalent |