510(k) K100707
- Device
- REPROCESSED PINS
- Applicant
- STERILMED, INC.
- 510(k) number
- K100707
- Product code
- NDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-25
- Date received
- 2010-03-12
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Threaded, Metallic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARRETT AHLBORG
- Address
- 11400 73rd Ave. N Maple Grove MN US 55369 55369
FDA Registration Numbers#
- 2029275
- 3011024991
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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