510(k) K093753
- Device
- MDPO FRAME SYSTEM
- Applicant
- MDPO, LLC
- 510(k) number
- K093753
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-26
- Date received
- 2009-12-07
- 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
- MARIE MARLOW
- Address
- 901 King St., Suite 200 Alexandria VA US 22314 22314
FDA Registration Numbers#
- 3015869493
- 1833920
- 3010673850
- 3002808145
- 3009350690
- 3015231789
- 3007887127
- 1000517406
- 3005061536
- 2532027
- 3025141
- 3004188066
- 3006783837
- 3009144915
- 3013011598
- 3004513872
- 2648920
- 3004358587
- 1835296
- 3015882686
- 3010502940
- 3006849754
- 3003860203
- 1226544
- 3035366890
- 3006694268
- 3013302242
- 3013510178
- 3009417901
- 3018269629
- 9613369
- 3008868758
- 3031240334
- 3003935342
- 3009973336
- 3007923096
- 1643264
- 2032112
- 3043355196
- 3003525643
- 3044090645
- 3007289093
- 3016084569
- 3003847101
- 1818910
- 9681465
- 3006395932
- 3000270450
- 3010287687
- 3038503932
- 3010041499
- 3034525
- 3007366790
- 1054811
- 3019767615
- 1828288
- 3022142628
- 3009746186
- 9710312
- 3010178296
- 1018470
- 3008951116
- 3009116370
- 1649390
- 9680825
- 3009540749
- 3011578810
- 3002807295
- 3006513362
- 3004748528
- 1835251
- 3000327445
- 3021680719
- 3010303097
- 3017521423
- 3002949614
- 3007993775
- 2027148
- 3010123172
- 1423662
Source Documents#
Other 510(k) Records For Product Code KTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | 2026-06-11 |
| 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 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 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 |
Legacy Summary#
summary
FDA Review#
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