510(k) K043289
- Device
- E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
- Applicant
- SIGNAL MEDICAL CORP.
- 510(k) number
- K043289
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-11
- Date received
- 2004-11-29
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUIS A SERAFIN, JR.
- Address
- 400 Pyramid Dr. Marysville MI US 48040 48040
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#
Other 510(k) Records For Product Code KTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 |
| 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 |
Legacy Summary#
summary
FDA Review#
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