Alphatec External Fixation System
FDA 510(k) K964400 · Alphatec Mfg., Inc.
510(k) numberK964400
Submission
- Device name
- Alphatec External Fixation System
- Applicant
- Alphatec Mfg., Inc.
Palm Desert, CA, US - Received
- November 4, 1996
- Decision date
- April 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
|---|---|---|
| K033090 | Icon Polyaxial Pedicle Screw SystemKWP · Traditional | 03/26/2004SE |
| K023299 | Alpha Mirage Top Tightening Spinal SystemMNI · Traditional | 12/11/2002SE |
| K020356 | Alpha Mirage Top Tightening Spinal SystemMNH · Traditional | 07/23/2002SE |
| K993513 | Deltaloc Anterior Cervical Plate SystemKWQ · Traditional | 04/26/2000SE |
| K993873 | Alphatec External Fixation System Compression/Distraction RodKTT · Traditional | 01/03/2000SE |
| K992350 | Pylon Intramedullaary Nail SystemHSB · Traditional | 09/22/1999SE |
| K980788 | Alphatec Wire External Fixation SystemJDW · Traditional | 05/22/1998SE |
| K951846 | Mirage Spinal System for Severe SpondylolisthesisKWP · Traditional | 02/14/1996SN |
| K926417 | Alphatec 130-150 Slotted Compression Hip ScrewKTT · Traditional | 09/28/1994SE |
| K930515 | Alpha Spinal SystemKWP · Traditional | 06/29/1994SESK |
Questions and answers
When was Alphatec External Fixation System cleared by the FDA?
Alphatec External Fixation System (K964400) received a 510(k) decision of Substantially Equivalent on April 28, 1997, 175 days after the submission was received.
What is the product code of K964400?
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.