FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTELON CMC SPACER ARTHRO
K Number: K061954
·
Decision Jun 1, 2007
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
7
Review Days
325
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Basic Information
- Device Name
- ARTELON CMC SPACER ARTHRO
- K Number
- K061954
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artimplant AB
- Date Received
- July 11, 2006
- Decision Date
- June 1, 2007
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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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 |
| K052830 | SPORTMESH | Jan 19, 2006 | 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 |