Spinal Concepts, Inc., Universal Bone Plate System II
FDA 510(k) K973586 · Spinal Concepts, Inc.
510(k) numberK973586
Submission
- Device name
- Spinal Concepts, Inc., Universal Bone Plate System II
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- September 22, 1997
- Decision date
- November 7, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | 05/19/2005SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | 04/15/2005SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | 07/01/2004SE |
| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
| K031837 | Modification to Fortitude Cement RestrictorJDK · Special | 07/24/2003SE |
Questions and answers
When was Spinal Concepts, Inc., Universal Bone Plate System II cleared by the FDA?
Spinal Concepts, Inc., Universal Bone Plate System II (K973586) received a 510(k) decision of Substantially Equivalent for Some Indications on November 7, 1997, 46 days after the submission was received.
What is the product code of K973586?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.