FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIORAPTOR 2.3 PK SUTURE ANCHOR
K Number: K071586
·
Decision Aug 17, 2007
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
8
Review Days
67
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Basic Information
- Device Name
- BIORAPTOR 2.3 PK SUTURE ANCHOR
- K Number
- K071586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Inc., Endoscopy Division
- Date Received
- June 11, 2007
- Decision Date
- August 17, 2007
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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|---|---|---|---|
| K121904 | GYNECOLOGY STERILIZATION TRAY | Mar 11, 2013 | Substantially Equivalent |
| K102982 | ENDOBUTTON DIRECT | Jan 5, 2011 | 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 |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | May 16, 2007 | Substantially Equivalent |
| K070167 | ENDOBUTTON DIRECT | Apr 12, 2007 | Substantially Equivalent |