510(k) K211086
- Device
- The Progen? Trochanteric Nail System
- Applicant
- Ortho Development Corporation
- 510(k) number
- K211086
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-21
- Date received
- 2021-04-12
- Regulation
- 888.3020
- Classification name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Divya Palan
- Address
- 12187 S. Business Park Dr. Draper UT US 84020 84020
FDA Registration Numbers
- 3015869492
- 3010364775
- 3014273424
- 3030714745
- 3026311512
- 3006128100
- 2029275
- 3006563559
- 3014315669
- 2183449
- 3010041499
- 3008650117
- 3003898228
- 3013756169
- 3026776
- 1835444
- 1423662
- 3014527928
- 3009532798
- 3017435639
- 3021008900
- 3006513362
- 9610622
- 3011053036
- 9611813
- 3010131578
- 3016851379
- 8010177
- 3010287737
- 3019269298
- 1422572
- 3033509898
- 3014967149
- 3010400367
- 3010047454
- 3005562917
- 3014004349
- 3005874553
- 9613910
- 3007993775
- 3002907620
- 3009971621
- 3003108161
- 3009973505
- 3010331645
- 3009996260
- 1043653
- 3008749819
- 3012755988
- 3009540749
- 3009158523
- 3014207283
- 2249697
- 3007344102
- 3008868758
- 3014315560
- 2028632
- 1644408
- 3006395932
- 3043620689
- 1424434
- 3006846433
- 3010097171
- 3003249380
- 3010470577
- 2031966
- 3009756327
- 3009144915
- 3008951116
- 3010363503
- 3009189869
- 3031261833
- 8043792
- 1818910
- 3008198024
- 3014833750
- 3006460162
- 1220477
- 3027339877
Source Documents
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