FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED PINS
K Number: K100707
·
Decision Jun 25, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
64
Review Days
105
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Basic Information
- Device Name
- REPROCESSED PINS
- K Number
- K100707
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterilmed, Inc.
- Date Received
- March 12, 2010
- Decision Date
- June 25, 2010
- Product Code
- NDM
- 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 |
|---|---|---|---|
| NDM | Pin, Fixation, Threaded, Metallic | FDA class 2 | Orthopedic |
Other Clearances by Sterilmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K152134 | Reprocessed Vessel Sealer | Jan 15, 2016 | Substantially Equivalent |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Aug 27, 2015 | Substantially Equivalent |