Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
FDA 510(k) clearance K143320 · decided 2015-04-23
Clearance details
- K-number
- K143320
- Device name
- Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-19
- Decision date
- 2015-04-23
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- HBE
- Device class
- 2
- Regulation number
- 882.4310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bon recall (Z-0980-2025) | Stryker Corporation | 2025-01-17 |
| stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during recall (Z-0981-2025) | Stryker Corporation | 2025-01-17 |
| stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone ceme recall (Z-0982-2025) | Stryker Corporation | 2025-01-17 |
| 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticatin recall (Z-0063-2025) | Stryker Corporation | 2024-10-11 |
| 5.0mm Round Fluted Bur, Super Long recall (Z-2204-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-07-14 |
| 6.0mm Round Fluted Bur, Super Long recall (Z-2205-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-07-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |