510(k) K180539
- Device
- Deformity Analysis And Correction Software (DACS) And Instrumentation
- Applicant
- Arrowhead Medical Device Technologies, LLC
- 510(k) number
- K180539
- Product code
- OSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-13
- Date received
- 2018-02-28
- Regulation
- 888.3030
- Classification name
- Software For Diagnosis/treatment
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas J. Twardzik
- Address
- 328 Poplar View Ln. E., Suite 2 Collierville TN US 38017 38017
FDA Registration Numbers#
- 8043792
- 3013510178
- 3000270450
- 3007366790
- 3011302692
- 1220246
- 3038503932
- 3010390570
- 3018064242
- 9680825
- 3007539489
- 3021008900
- 1833986
- 3004464325
- 3002907620
- 3011295718
- 9611863
- 1020279
- 1051526
- 3009973699
- 3034676720
- 2183449
- 3008868758
- 3010363503
- 3011276773
- 1018470
- 3009417901
- 1833920
- 1834331
- 3006460162
- 3008812560
- 3036756245
- 1043653
- 1526534
- 3005497913
- 3010178296
- 3025603301
- 1643264
- 3033509898
- 9681191
- 3008744062
Source Documents#
Other 510(k) Records For Product Code OSN #
Legacy Summary#
summary
FDA Review#
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