Reprocessed External Fixation Devices
FDA 510(k) K052918 · Alliance Medical Corp.
510(k) numberK052918
Submission
- Device name
- Reprocessed External Fixation Devices
- Applicant
- Alliance Medical Corp.
Phoenix, AZ, US - Received
- October 17, 2005
- Decision date
- January 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060648 | Reprocessed Phacoemulsification TipsNKX · Traditional | 03/19/2007SE |
| K061045 | Reprocessed Electrophysiology CathetersNLH · Traditional | 08/31/2006SE |
| K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom)JOW · Traditional | 04/04/2006SE |
| K060049 | Reprocessed Compression SleevesJOW · Traditional | 02/24/2006SE |
| K060091 | Alliance Medical Corporation Reprocessed Compression SleevesJOW · Traditional | 02/17/2006SE |
| K053316 | Reprocessed Compression SleevesJOW · Traditional | 02/13/2006SE |
| K052603 | Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional | 11/16/2005SE |
| K052414 | Reprocessed Electrophysiology CatheterNLH · Traditional | 11/16/2005SE |
| K050518 | Reprocessed Phacoemuisification TipsNKX · Traditional | 09/23/2005SE |
| K052064 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | 08/25/2005SE |
Questions and answers
When was Reprocessed External Fixation Devices cleared by the FDA?
Reprocessed External Fixation Devices (K052918) received a 510(k) decision of Substantially Equivalent on January 27, 2006, 102 days after the submission was received.
What is the product code of K052918?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.