FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE UNI-CLIP STAPLE
K Number: K011716
·
Decision Aug 30, 2001
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
28
Review Days
87
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Basic Information
- Device Name
- THE UNI-CLIP STAPLE
- K Number
- K011716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Deal, S.A.
- Date Received
- June 4, 2001
- Decision Date
- August 30, 2001
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by New Deal, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K070241 | MODIFICATION TO LAPIDUS PLATE | Feb 8, 2007 | Substantially Equivalent |
| K070160 | MODIFICATION TO TTC PLATES | Feb 8, 2007 | Substantially Equivalent |
| K063820 | LISFRANC PLATE | Feb 8, 2007 | Substantially Equivalent |
| K060474 | LISFRANC PLATE | Aug 3, 2006 | Substantially Equivalent |
| K061765 | KALIX II IMPLANT | Jul 18, 2006 | Substantially Equivalent |
| K061594 | LARGE UNI-CLIP STAPLE | Jul 3, 2006 | Substantially Equivalent |
| K060476 | LAPIDUS PLATE | May 17, 2006 | Substantially Equivalent |
| K060473 | TTC PLATE | May 17, 2006 | Substantially Equivalent |
| K053093 | KALIX II IMPLANT, MODEL 141 0XX WITH XX | Dec 7, 2005 | Substantially Equivalent |
| K052152 | B-BOP PLATE | Sep 13, 2005 | Substantially Equivalent |