510(k) K101375
- Device
- TRIMED X-FIX
- Applicant
- TRIMED, INC.
- 510(k) number
- K101375
- Product code
- NDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-15
- Date received
- 2010-05-17
- Regulation
- 888.3040
- Classification name
- System, External Fixator (with Metallic Invasive Components)
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KELLI ANDERSON
- Address
- 28337 Maitland Ln. Saugus CA US 91350 91350
FDA Registration Numbers#
- 3010131978
- 3021226419
- 1220246
Source Documents#
Other 510(k) Records For Product Code NDK #
Legacy Summary#
summary
FDA Review#
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