Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates
FDA 510(k) K100614 · Blackstone Medical, Inc.
510(k) numberK100614
Submission
- Device name
- Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- March 4, 2010
- Decision date
- May 4, 2010
- 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
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| 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 |
|---|---|---|
| K093926 | Firebird Spinal Fixation SystemNKB · Traditional | 07/28/2010SE |
| K092624 | Firebird Spinal Fixation SystemNKB · Special | 09/25/2009SE |
| K082797 | Blackstone Pedicle Screw SystemNKB · Special | 10/17/2008SE |
| K081684 | Blackstone Pedicle Screw SystemNKB · Traditional | 09/15/2008SE |
| K082235 | Blackstone Pillar XL PEEK SpacersMAX · Special | 09/04/2008SE |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceOVD · Special | 08/28/2008SE |
| K081177 | Blackstone Medical, Inc., Pillar Spacer SystemMAX · Traditional | 07/23/2008SE |
| K080407 | Blackstone SFS Parallel Rod ConnectorsMNI · Special | 03/13/2008SE |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemKWP · Special | 03/13/2008SE |
| K073420 | Blackstone Ascent Multiaxial ScrewsKWP · Special | 02/14/2008SE |
Questions and answers
When was Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates cleared by the FDA?
Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates (K100614) received a 510(k) decision of Substantially Equivalent on May 4, 2010, 61 days after the submission was received.
What is the product code of K100614?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.