FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
NEWDEAL INTERPHALANGEAL IMPLANT
K Number: K103623
·
Decision Mar 20, 2012
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
10
Review Days
466
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Basic Information
- Device Name
- NEWDEAL INTERPHALANGEAL IMPLANT
- K Number
- K103623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Newdeal Sas
- Date Received
- December 10, 2010
- Decision Date
- March 20, 2012
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Newdeal Sas
| K Number | Device Name | ||
|---|---|---|---|
| K093914 | NEWDEAL COMPRESSION PLATES | Apr 14, 2011 | Substantially Equivalent |
| K093781 | MODIFIED: NEWDEAL HALLU PLATES | Jan 22, 2010 | Substantially Equivalent |
| K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL | Jul 29, 2009 | Substantially Equivalent |
| K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | Jul 10, 2009 | Substantially Equivalent |
| K091609 | NEWDEAL COMPRESSION PLATE | Jun 30, 2009 | Substantially Equivalent |
| K073375 | NEWDEAL TIBIAXYS SYSTEM | Feb 21, 2008 | Substantially Equivalent |
| K071639 | QWIX POSITIONING SCREW | Jul 9, 2007 | Substantially Equivalent |
| K070447 | NEWDEAL COMPRESSION PLATE | Mar 29, 2007 | Substantially Equivalent |
| K063831 | BASAL DORSAL PLATES | Feb 7, 2007 | Substantially Equivalent |