Kronner Universal Frame External Fixation
FDA 510(k) K871247 · Kronner Medical
510(k) numberK871247
Submission
- Device name
- Kronner Universal Frame External Fixation
- Applicant
- Kronner Medical
Roseburg, OR, US - Received
- March 30, 1987
- Decision date
- May 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K894228 | Kronner Spherical CuttersHWT · Traditional | 07/23/1990SE |
| K895171 | Blood Gas Safety SyringeCBT · Traditional | 11/07/1989SE |
| K895173 | Skeletal Fixation PinJDW · Traditional | 09/12/1989SE |
| K895172 | Kronner Sacral Pin GuideLXH · Traditional | 09/12/1989SE |
| K871248 | Kronner Colles-Forearm External FixationKTT · Traditional | 06/03/1987SE |
| K871249 | Kronner Bi-Planer Tibia External FixationKTT · Traditional | 05/22/1987SE |
Questions and answers
When was Kronner Universal Frame External Fixation cleared by the FDA?
Kronner Universal Frame External Fixation (K871247) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 53 days after the submission was received.
What is the product code of K871247?
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.