510(k) K091587
- Device
- MERCURY SPINAL SYSTEM
- Applicant
- SPINAL ELEMENTS, INC.
- 510(k) number
- K091587
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-01
- Date received
- 2009-06-02
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERRI DIMARTINO
- Address
- 2744 Loker Ave. W. Suite 100 Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3003935342
- 3012131184
- 1223434
- 3007604895
- 3011221483
- 1722511
- 3010160527
- 3011964577
- 3009882675
- 1835572
- 3011170410
- 3008455034
- 3014938863
- 9615766
- 9617616
- 8020776
- 3006017180
- 3043234953
- 3009173317
- 3030412764
- 3011577940
- 3007993775
- 3015941638
- 3007675554
- 3030655570
- 3006378738
- 3007539489
- 3002808227
- 3005596514
- 3010123206
- 3010370500
- 3008992889
- 3006460162
- 3003639920
- 3014387294
- 3004719693
- 3013055499
- 3014763043
- 2183449
- 3010866843
- 3013011598
- 3007441485
- 1531050
- 3010041430
- 3011874600
- 3015831087
- 3021948057
- 3013548554
- 3006563559
- 3002976036
- 9616944
- 3007700286
- 2134470
- 3009165919
- 9616062
- 1720929
- 1526534
- 2648666
- 1000493591
- 9611813
- 3007887127
- 3019837678
- 1066368
- 1828288
- 3015443158
- 1047843
- 9617297
- 3009050824
- 1834331
- 3014257776
- 1056553
- 3009888740
- 3010531060
- 1000200989
- 3039169546
- 3029933740
- 3014725904
- 9615014
- 3008110533
Source Documents#
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026-09-27 |
| K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026-09-23 |
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-09-17 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | 2026-09-14 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-09-04 |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | 2026-07-24 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026-07-14 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-07-01 |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System | Globus Medical, Inc. | 2026-05-07 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 |
Legacy Summary#
summary
FDA Review#
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