510(k) K964416
- Device
- SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K964416
- Product code
- KWQ
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1997-03-17
- Date received
- 1996-10-04
- Regulation
- 888.3060
- Classification name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANE T BROWN
- Address
- 1690 Russell Rd. P.O. Box 1766 Paoli PA US 19301 19301
FDA Registration Numbers#
- 3014937101
- 3009051471
- 3004499989
- 3010197239
- 1526534
- 3010197224
- 9681465
- 9614209
- 3010120339
- 3005641619
- 2183449
- 9611390
- 2032093
- 3004635447
- 2532027
- 3015877656
- 3008114965
- 3010160527
- 3010560653
- 3004941535
- 3010866843
- 3015991317
- 3009704301
- 3017528621
- 9617297
- 2530808
- 3019837678
- 3011301313
- 3011181154
- 3013011598
- 1828288
- 3010123206
- 3009144915
- 3004142400
- 3016084569
- 9615800
- 3023852420
- 3010120148
- 1030489
- 3009971621
- 3010041993
- 3010365473
- 3009173317
- 3010326971
- 3013422238
- 3009887475
- 3010120104
- 3005325790
- 3023138345
- 3009756327
- 3006846753
- 1420032
- 3009959868
- 1935627
- 3010162973
- 1530530
- 1834331
- 3006356043
- 3036756245
- 3009790163
- 3010057495
- 3002807561
- 3020703621
- 1531174
- 3008110533
- 3010462278
- 1833824
- 1528646
- 2133928
- 3000270450
- 3008583793
- 1833506
- 2029275
- 1835444
- 1526439
- 3005497913
- 3009973699
- 3002807112
- 3006404019
- 3015426608
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWQ #
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|---|---|---|---|
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
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| K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026-04-22 |
| K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025-08-28 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
Legacy Summary#
summary
FDA Review#
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