Laminoplasy Plating System
FDA 510(k) K103284 · Aesculap Implant Systems, Inc.
510(k) numberK103284
Submission
- Device name
- Laminoplasy Plating System
- Applicant
- Aesculap Implant Systems, Inc.
Center Valley, PA, US - Received
- November 5, 2010
- Decision date
- December 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQW – Orthosis, Spine, Plate, Laminoplasty, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Other 510(k)s with product code NQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | Curiteva, Inc. | 10/28/2024SE |
| K242784 | Vy Spine VyLam Laminoplasty SystemNQW · Special | Vy Spine, LLC | 10/16/2024SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | Vy Spine, LLC | 10/10/2023SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | Curiteva, Inc. | 06/28/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | Medtronic Sofamor Danek | 12/13/2021SE |
| K191927 | Hinged Laminoplasty SystemNQW · Traditional | Life Spine, Inc. | 09/20/2019SE |
| K191169 | NuVasive® Camber Laminoplasty SystemNQW · Traditional | Nu Vasive, Incorporated | 07/03/2019SE |
| K181717 | Life Spine Laminoplasty SystemNQW · Traditional | Life Spine, Inc. | 10/12/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | Choicespine, LP | 01/19/2018SE |
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| 510(k) | Device | Decision |
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| K210963 | ENNOVATE Spinal SystemNKB · Traditional | 07/19/2021SE |
| K180433 | Ennovate®NKB · Traditional | 04/26/2018SE |
| K162134 | ENNOVATE Spinal SystemNKB · Traditional | 12/14/2016SE |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional | 07/08/2016SE |
| K153629 | ArcadiusXP C Spinal SystemOVE · Traditional | 05/25/2016SE |
| K153396 | Aesculap OrthoPilot Next GenerationOLO · Traditional | 05/16/2016SE |
| K151938 | S4 Cervical Spinal and Occiput SystemsNKG · Traditional | 10/21/2015SE |
| K151056 | Aesculap T-Space PEEK and XP Spinal SystemMAX · Traditional | 08/13/2015SE |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special | 05/29/2015SE |
Questions and answers
When was Laminoplasy Plating System cleared by the FDA?
Laminoplasy Plating System (K103284) received a 510(k) decision of Substantially Equivalent on December 2, 2010, 27 days after the submission was received.
What is the product code of K103284?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.