FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITEK PDS/PGA STAPLE
K Number: K021953
·
Decision Dec 20, 2002
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
10
Review Days
190
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Basic Information
- Device Name
- MITEK PDS/PGA STAPLE
- K Number
- K021953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitek Worldwide
- Date Received
- June 13, 2002
- Decision Date
- December 20, 2002
- 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 Mitek Worldwide
| K Number | Device Name | ||
|---|---|---|---|
| K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW | Mar 31, 2004 | Substantially Equivalent |
| K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH | Oct 15, 2003 | Substantially Equivalent |
| K032078 | MITEK MICRO QUICKANCHOR | Aug 25, 2003 | Substantially Equivalent |
| K030995 | MINILOK QUICKANCHOR PLUS | Jun 26, 2003 | Substantially Equivalent |
| K031519 | CUFFLOK ANCHOR | Jun 6, 2003 | Substantially Equivalent |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | May 30, 2003 | Substantially Equivalent |
| K024115 | MICROFIX QUICKANCHOR PLUS | Mar 13, 2003 | Substantially Equivalent |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | Dec 27, 2002 | Substantially Equivalent |
| K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR | Jul 1, 2002 | Substantially Equivalent |