FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOBUTTON DIRECT
K Number: K102982
·
Decision Jan 5, 2011
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- ENDOBUTTON DIRECT
- K Number
- K102982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Inc., Endoscopy Division
- Date Received
- October 7, 2010
- Decision Date
- January 5, 2011
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Smith & Nephew Inc., Endoscopy Division
| K Number | Device Name | ||
|---|---|---|---|
| K121904 | GYNECOLOGY STERILIZATION TRAY | Mar 11, 2013 | Substantially Equivalent |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | Nov 3, 2008 | Substantially Equivalent |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | Jul 16, 2008 | Substantially Equivalent |
| K072785 | TWINFIX FT PK | Dec 10, 2007 | Substantially Equivalent |
| K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | Aug 17, 2007 | Substantially Equivalent |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | May 16, 2007 | Substantially Equivalent |
| K070167 | ENDOBUTTON DIRECT | Apr 12, 2007 | Substantially Equivalent |