Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws
FDA 510(k) K081380 · K2m, Inc.
510(k) numberK081380
Submission
- Device name
- Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- May 16, 2008
- Decision date
- November 19, 2008
- 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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| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
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Questions and answers
When was Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws cleared by the FDA?
Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws (K081380) received a 510(k) decision of Substantially Equivalent on November 19, 2008, 187 days after the submission was received.
What is the product code of K081380?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.