Stryker Corporation
FDA 510(k) & PMA Approved Devices — 43 products
Total Devices43
Categories24
Latest FDA decision2023-08-18
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | HRX | 2018-12-21 | View |
| 510(k) | K180327 | Stryker iVAS 13g Bone Biopsy Kit | KNW | 2018-02-26 | View |
| 510(k) | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | HRX | 2018-01-25 | View |
| 510(k) | K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap | OLO | 2017-10-18 | View |
| 510(k) | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | NKB | 2017-10-10 | View |
| 510(k) | K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | KNW | 2017-10-05 | View |
| 510(k) | K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | ERL | 2017-09-15 | View |
| 510(k) | K171807 | ES2 Neuromonitoring Accessory Instruments | PDQ | 2017-07-18 | View |
| 510(k) | K170242 | MultiGen™ 2 RF Generator System | GXD | 2017-05-25 | View |
| 510(k) | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | NKB | 2017-05-16 | View |
| 510(k) | K162937 | Stryker OrthoMap Versatile Hip System | OLO | 2017-02-23 | View |
| 510(k) | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | HAW | 2017-02-22 | View |
| 510(k) | K161514 | Precision Thin Reciprocating Blade, 0.010in. | EQJ | 2017-01-17 | View |
| 510(k) | K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | HRX | 2016-11-01 | View |
| PMA | P960053 | Prosthesis, finger, constrained, metal/polymer | KWG | 2016-08-09 | View |
| 510(k) | K160715 | AccuLIF TL and PL Cage | MAX | 2016-07-08 | View |
| 510(k) | K160978 | LITe BIO Delivery System | FMF | 2016-07-08 | View |
| 510(k) | K160050 | SERFAS 90-S Electrosurgical Probe | GEI | 2016-05-03 | View |
| 510(k) | K153407 | Stryker Neptune 3 Waste Management System | JCX | 2016-04-25 | View |
| 510(k) | K160693 | Neptune E-SEP Smoke Evacuation Pencil | GEI | 2016-04-13 | View |
No matching devices.
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