510(k) K960014
- Device
- PRACTIFIX EXTERNAL FIXATION SYSTEM
- Applicant
- ORTHOPAEDIC INNOVATIONS, INC.
- 510(k) number
- K960014
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-18
- Date received
- 1996-01-02
- 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
- CAROLYN M STEELE
- Address
- 825 S. 8th St. Suite 700 Minneapolis MN US 55404 55404
FDA Registration Numbers#
- 3010287687
- 1835251
- 3010390570
- 3004049923
- 1051526
- 8010916
- 2183946
- 3003525643
- 3016084569
- 9615128
- 1649390
- 3013055499
- 3021008900
- 3016438694
- 3005157180
- 9681465
- 3010158639
- 3015876273
- 3005497913
- 1450662
- 3045159437
- 3007441485
- 3015882686
- 3010041499
- 3006801265
- 3001239363
- 3032391
- 3013011598
- 3007334927
- 3008868758
- 3015877656
- 1649379
- 3006179046
- 3015212339
- 2249615
- 3010120104
- 3008812560
- 3009201148
- 1833824
- 1833920
- 9611863
- 3009971621
- 3009350690
- 3011187779
- 3004358587
- 2090040
- 3006272282
- 3044090645
- 3013176080
- 3017168764
- 1057425
- 3031800723
- 1054811
- 3010009693
- 1835444
- 3008102042
- 3003860203
- 3034525
- 3026593233
- 3006513362
- 3018269629
- 3012711663
- 3038503932
- 8043792
- 3014680795
- 3010041993
- 1834331
- 3005061536
- 3003108161
- 3009116370
- 3009513193
- 3015183635
- 3003249380
- 3029933740
- 3009973505
- 3022142628
- 3011534620
- 1818910
- 3014302784
- 3017521423
Source Documents#
Other 510(k) Records For Product Code KTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263083 | Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2026-10-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases