510(k) K790501
- Device
- Pediatric Osteotomy System
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K790501
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-10
- Date received
- 1979-03-13
- Regulation
- 888.3030
- Classification name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015869492
- 3014273424
- 9616680
- 2027148
- 2029275
- 3014129047
- 3014315669
- 2183449
- 3022142628
- 3010041499
- 9610612
- 3008650117
- 3009201148
- 3009826895
- 1835444
- 1423662
- 3021008900
- 3013194153
- 3003847101
- 3006513362
- 8010177
- 3033509898
- 3014967149
- 3010303097
- 3010041993
- 3010047454
- 2648920
- 3007993775
- 3012711663
- 3017168764
- 3002907620
- 3009971621
- 3015398319
- 2032112
- 2011171
- 3003108161
- 3009973505
- 3010331645
- 3011276773
- 1833824
- 3012755988
- 3031800723
- 1043653
- 3009540749
- 3007289093
- 9681191
- 3008868758
- 3014315560
- 3011578810
- 3006395932
- 2532027
- 1424434
- 3011656326
- 3014725904
- 3003249380
- 1018470
- 3017980266
- 3009144915
- 3008951116
- 3010363503
- 3007887127
- 9611863
- 1721686
- 8043792
- 3014680795
- 1057425
- 1818910
- 3005893246
- 2032521
- 3006460162
- 3005061536
- 3009888740
- 3015183635
- 3003761012
- 3008812560
- 3006001176
- 3015869493
- 3006783837
- 3015231789
Source Documents#
510(k) summary PDF not indicated by FDA
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| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 |