GALLERY LAMINOPLASTY FIXATION SYSTEM
FDA 510(k) clearance K100805 · decided 2010-07-20
Clearance details
- K-number
- K100805
- Device name
- GALLERY LAMINOPLASTY FIXATION SYSTEM
- Applicant
- Biomet Spine (Aka Ebi, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2010-03-22
- Decision date
- 2010-07-20
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- NQW
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AQUA Laminoplasty Systems (K252930) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| Curiteva Porous PEEK Laminoplasty System (K243137) | Curiteva, Inc. | 2024-10-28 |
| Vy Spine™ VyLam™ Laminoplasty System (K242784) | Vy Spine, LLC | 2024-10-16 |
| Vy Spine™ VyLam™ Laminoplasty System (K232471) | Vy Spine, LLC | 2023-10-10 |
| Curiteva Laminoplasty System (K231232) | Curiteva, Inc. | 2023-06-28 |
| Centerpiece Plate Fixation System (K212428) | Medtronic Sofamor Danek | 2021-12-13 |
| Hinged Laminoplasty System (K191927) | Life Spine, Inc. | 2019-09-20 |
| NuVasive® Camber Laminoplasty System (K191169) | Nu Vasive, Incorporated | 2019-07-03 |
| Life Spine Laminoplasty System (K181717) | Life Spine, Inc. | 2018-10-12 |
| Choice Spine Laminoplasty™ Fixation System (K173215) | Choicespine, LP | 2018-01-19 |
| HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413) | Globus Medical, Inc. | 2017-07-14 |
| Xspan Laminoplasty Fixation System (K160114) | X-Spine Systems, Inc. | 2016-03-15 |
Recalls involving this device
No recalls on record reference this clearance.