FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRYKER TRAUMA TRAY
K Number: K894470
·
Decision Aug 18, 1989
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
124
Review Days
31
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRYKER TRAUMA TRAY
- K Number
- K894470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Stryker Corp.
- Date Received
- July 18, 1989
- Decision Date
- August 18, 1989
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYZ), ordered by most recent decision date.
OtoSet- Ear Cleaning System
FDA 510(k)
FDA Class 1
·General Hospital
SINGLE CANNULA EXTENDED APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
TISSU TRANS HARVEST TUBING
FDA 510(k)
FDA Class 1
·General Hospital
TISSU-TRANS
FDA 510(k)
FDA Class 1
·General Hospital
QS DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
IRRIGATION SYRINGE KIT
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Stryker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K230045 | HipCheck | Sep 29, 2023 | Substantially Equivalent |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Jul 12, 2019 | Substantially Equivalent |
| K182359 | HipCheck | Dec 13, 2018 | Substantially Equivalent |
| K143399 | Stryker Footed Attachments and Cutting Accessories | May 8, 2015 | Substantially Equivalent |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Apr 23, 2015 | Substantially Equivalent |
| K150449 | LITe Plate System | Mar 20, 2015 | Substantially Equivalent |
| K142381 | Xia 3 Spinal System | Oct 21, 2014 | Substantially Equivalent |
| K133671 | ICONIX ALL SUTURE ANCHORS | Feb 28, 2014 | Substantially Equivalent |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Mar 12, 2013 | Substantially Equivalent |
| K122284 | HOFFMANN 3 | Oct 24, 2012 | Substantially Equivalent |