System 9 Sterile Battery Container
FDA 510(k) K242834 · Stryker Instruments
510(k) numberK242834
Submission
- Device name
- System 9 Sterile Battery Container
- Applicant
- Stryker Instruments
Portage, MI, US - Received
- September 19, 2024
- Decision date
- January 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
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| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
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| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
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Questions and answers
When was System 9 Sterile Battery Container cleared by the FDA?
System 9 Sterile Battery Container (K242834) received a 510(k) decision of Substantially Equivalent on January 16, 2025, 119 days after the submission was received.
What is the product code of K242834?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.