510(k) K220297
- Device
- True Tulip, True M.I.S.
- Applicant
- Innovative Surgical Designs, Inc.
- 510(k) number
- K220297
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-16
- Date received
- 2022-02-02
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jon Rinehart
- Address
- 3903 S. Walnut St. Bloomington IN US 47401 47401
FDA Registration Numbers#
- 3043620689
- 3009217531
- 3005497913
- 3013546462
- 3011500362
- 3016244279
- 3010047454
- 1222773
- 3006639944
- 1226544
- 9681465
- 3006783837
- 3010120339
- 1000461041
- 3005819474
- 3019767615
- 3003477135
- 3004893332
- 3012447612
- 3023138345
- 3016084569
- 3019878714
- 3005031160
- 3007334927
- 3009971621
- 1225838
- 3013055499
- 3039169546
- 3002806603
- 3007604895
- 3013491327
- 3017565094
- 9615766
- 3018094310
- 1043214
- 3011277306
- 3003855635
- 3011015572
- 3015869493
- 3012770122
- 3007700286
- 3014387294
- 3001239363
- 2249608
- 3003525643
- 3008959459
- 3007441485
- 3010370500
- 3038505140
- 3010123206
- 3008583793
- 3008992889
- 3029933740
- 1720929
- 1835296
- 3003541440
- 3006791286
- 1224360
- 3010370554
- 3004142400
- 1423662
- 3009173317
- 3009887475
- 3014003062
- 3007279845
- 9611274
- 3010531060
- 3006128100
- 3012599928
- 1319660
- 1828464
- 3006460162
- 3007997036
- 3010120104
- 3013034344
- 3016438694
- 3010663372
- 3017036472
- 3010197239
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-04-03 |
Legacy Summary#
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FDA Review#
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