510(k) K142114
- Device
- XIA 4.5 SPINAL SYSTEM
- Applicant
- STRYKER CORPORATION
- 510(k) number
- K142114
- Product code
- PGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-10-27
- Date received
- 2014-08-04
- Regulation
- 510(k) Premarket Notification
- Classification name
- Growing Rod System
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARRY T HAYECK, PH.D.
- Address
- 2 Pearl Ct. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3000270450
- 3004142400
- 3004024955
- 9617544
- 3009010435
- 3006984710
- 3010440433
- 3015216945
- 3014725904
- 3007344102
- 1824199
- 3030412764
- 2183946
- 3012120772
- 3003761012
- 3004774118
- 3004464325
- 2647346
- 3004188066
- 2531477
- 3003525643
- 3010370500
- 3008114965
- 3009973699
- 1526439
- 3010041430
- 3008868758
- 3016050940
- 3010363503
- 3009417901
- 3014252644
- 3018094310
- 3010386387
- 3006460162
- 1526534
- 1531174
- 1030489
- 3010047454
- 3003120897
- 3012447612
- 2031966
- 3009144915
Source Documents#
Other 510(k) Records For Product Code PGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. | 2026-01-15 |
| K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | 2025-03-14 |
| K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022-12-19 |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | 2020-02-13 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System | Medos International SARL | 2019-09-24 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018-06-29 |
| K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | 2018-03-15 |
| K172979 | NuVasive® Growth Rod Conversion Set | Nu Vasive, Incorporated | 2017-11-06 |
| K161028 | K2M Growing Spine System | K2m, Inc. | 2016-07-22 |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 |
| K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | Medos Sarl | 2014-08-22 |
| K140750 | SHILLA GROWTH GUIDANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-07-17 |
| K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | Medtronic Sofamor Danek USA | 2014-02-25 |
Legacy Summary#
summary
FDA Review#
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