Reprocessed External Fixation Device
FDA 510(k) K061759 · Ascent Healthcare Solutions
510(k) numberK061759
Submission
- Device name
- Reprocessed External Fixation Device
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- June 22, 2006
- Decision date
- September 5, 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 |
|---|---|---|
| K111600 | Reprocessed Hand Activate Sealer/DividerNUJ · Traditional | 11/15/2011SE |
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100909 | Reprocessed Compression SleevesJOW · Traditional | 07/23/2010SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | 05/28/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
Questions and answers
When was Reprocessed External Fixation Device cleared by the FDA?
Reprocessed External Fixation Device (K061759) received a 510(k) decision of Substantially Equivalent on September 5, 2006, 75 days after the submission was received.
What is the product code of K061759?
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.