Boundary Anterior Lumbar Buttress Plate
FDA 510(k) K173091 · Nvision Biomedical Technologies, LLC
510(k) numberK173091
Submission
- Device name
- Boundary Anterior Lumbar Buttress Plate
- Applicant
- Nvision Biomedical Technologies, LLC
San Antonio, TX, US - Received
- September 29, 2017
- Decision date
- December 6, 2017
- 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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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
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| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
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Questions and answers
When was Boundary Anterior Lumbar Buttress Plate cleared by the FDA?
Boundary Anterior Lumbar Buttress Plate (K173091) received a 510(k) decision of Substantially Equivalent on December 6, 2017, 68 days after the submission was received.
What is the product code of K173091?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.