Tamarack Anterior Thoracolunbar
FDA 510(k) K050390 · Alphatec/Nexmed
510(k) numberK050390
Submission
- Device name
- Tamarack Anterior Thoracolunbar
- Applicant
- Alphatec/Nexmed
Carlsbad, CA, US - Received
- February 16, 2005
- Decision date
- March 14, 2005
- 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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| 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 |
|---|---|---|
| K050830 | Zodiac Spinal Fixation SystemKWP · Traditional | 06/22/2005SE |
| K051286 | Zodiac Spinal Fixation SystemMNH · Special | 06/17/2005SE |
| K050553 | Novel VBR Spinal SystemMQP · Special | 04/18/2005SE |
| K050078 | Roc Lumbar Plating SystemMNH · Traditional | 02/18/2005SE |
| K042252 | Nexflex Total Hip SystemLPH · Special | 12/06/2004SE |
| K042673 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | 10/27/2004SE |
| K042440 | Alphatec Femoral Trochanteric Nail (FTN) SystemHSB · Traditional | 10/07/2004SE |
| K042201 | Novel VBR Spinal SystemMQP · Traditional | 10/07/2004SE |
Questions and answers
When was Tamarack Anterior Thoracolunbar cleared by the FDA?
Tamarack Anterior Thoracolunbar (K050390) received a 510(k) decision of Substantially Equivalent on March 14, 2005, 26 days after the submission was received.
What is the product code of K050390?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.