PIN RETRACTORS
FDA 510(k) clearance K771418 · decided 1977-09-22
Clearance details
- K-number
- K771418
- Device name
- PIN RETRACTORS
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-01
- Decision date
- 1977-09-22
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HTY
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZipToe™ Hammertoe Fusion System (K253325) | Toetal Solutions | 2025-12-29 |
| Impact PEEK Union Nail System (K252657) | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| RONAVIS – FX (FX-001) (K250315) | AIRS, Inc. | 2025-08-01 |
| PediFlex™ Flexible Nail System (K251362) | OrthoPediatrics Corp. | 2025-06-24 |
| Impact PEEK Union Nail System (K250646) | Nvision Biomedical Technologies | 2025-06-11 |
| Biomet Kirschner Wires (K-Wires) (K241014) | Biomet, Inc. | 2024-05-22 |
| OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (K231272) | OSSIO , Ltd. | 2023-12-01 |
| Hammerdesis™ Interphalangeal Fusion System (K231147) | Intelivation | 2023-09-14 |
| OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750) | OSSIO , Ltd. | 2023-09-13 |
| Electro-Spec Steri-Caps (K231905) | Electro-Spec, Inc. | 2023-08-14 |
| Tyber Medical Pin and Wire System (various) (K231339) | Tyber Medical, LLC | 2023-07-06 |
| Hammertoe Truss System (HTS) (K221283) | 4Web Medical, Inc. | 2022-09-06 |
Recalls involving this device
No recalls on record reference this clearance.
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 |