Synthes Uss (10.0MM Side Opening Screws)
FDA 510(k) K003061 · Synthes
510(k) numberK003061
Submission
- Device name
- Synthes Uss (10.0MM Side Opening Screws)
- Applicant
- Synthes
Paoli, PA, US - Received
- October 2, 2000
- Decision date
- October 30, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
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| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
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| 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 |
|---|---|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating SystemHRS · Traditional | 03/10/2026SE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating SystemHRS · Traditional | 03/09/2026SE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
Questions and answers
When was Synthes Uss (10.0MM Side Opening Screws) cleared by the FDA?
Synthes Uss (10.0MM Side Opening Screws) (K003061) received a 510(k) decision of Substantially Equivalent on October 30, 2000, 28 days after the submission was received.
What is the product code of K003061?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.