Dogbone Acfs
FDA 510(k) K994383 · Theken Surgical
510(k) numberK994383
Submission
- Device name
- Dogbone Acfs
- Applicant
- Theken Surgical
Barberton, OH, US - Received
- December 28, 1999
- Decision date
- February 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050058 | Theken Reveal VBR SystemMQP · Traditional | 05/17/2005SE |
| K041592 | Coral Spinal SystemKWP · Traditional | 09/16/2004SE |
| K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemMQP · Traditional | 02/20/2004SE |
| K012462 | Theken Large Cement RestrictorJDK · Traditional | 10/29/2001SESU |
| K012278 | Theken Small Cement RestrictorJDK · Traditional | 10/17/2001SESU |
| K010466 | Tether AcfsKWQ · Traditional | 05/16/2001SE |
| K994382 | Nonlinear Taper Lag ScrewHWC · Traditional | 03/10/2000SE |
| K983622 | Bodyform Thoraco-Lumbar Fixation SystemKWQ · Traditional | 12/30/1998SE |
Questions and answers
When was Dogbone Acfs cleared by the FDA?
Dogbone Acfs (K994383) received a 510(k) decision of Substantially Equivalent on February 4, 2000, 38 days after the submission was received.
What is the product code of K994383?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.