510(k) K132740
- Device
- SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
- Applicant
- SPINEFRONTIER, INC.
- 510(k) number
- K132740
- Product code
- NQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-26
- Date received
- 2013-09-03
- Regulation
- 888.3050
- Classification name
- Orthosis, Spine, Plate, Laminoplasty, Metal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL L SPEIDEL
- Address
- 500 Cummings Center, Suite 3500 Beverly MA US 01915 01915
FDA Registration Numbers#
- 3036756245
- 2031966
- 3003120897
- 3009144915
- 1835251
- 1824199
- 3010120148
- 3012131184
- 3009959868
- 1526439
- 3004024955
- 3021559833
- 2183449
- 1220477
- 9610612
- 9617544
- 3010032903
- 3003761012
- 3008812560
- 3012447612
- 3015869493
- 3006783837
- 3016050940
- 3043543260
- 3003477135
- 3005819474
- 3004499989
- 3005031160
- 3000270450
- 1030489
- 9611813
- 1000200989
- 2530808
- 3009417901
- 1424263
- 3006846753
- 3015440604
- 3010041430
- 3010097171
- 3010120135
- 3004188066
- 2647346
- 2134470
- 3033509898
- 3004142400
- 1224360
- 2183946
- 3003935342
- 3010041993
- 1226544
- 3010047454
- 3012120772
- 3008114965
- 3007993775
- 3018094310
- 3009973505
- 3010863450
- 3016438694
- 3015399803
- 3008868758
- 3030412764
- 1526534
- 1424434
- 3014725904
- 3025603301
- 3019837678
- 1833920
Source Documents#
Other 510(k) Records For Product Code NQW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024-10-28 |
| K242784 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2024-10-16 |
| K232471 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2023-10-10 |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023-06-28 |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | 2021-12-13 |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019-09-20 |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019-07-03 |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018-10-12 |
| K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | 2018-01-19 |
| K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | 2017-07-14 |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016-03-15 |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015-03-23 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | 2013-05-09 |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | 2013-02-07 |
Legacy Summary#
summary
FDA Review#
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