Wells Johnson Fixation System
FDA 510(k) K945500 · Wells Johnson Co.
510(k) numberK945500
Submission
- Device name
- Wells Johnson Fixation System
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- November 9, 1994
- Decision date
- September 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Stryker Craniomaxillofacial
| 510(k) | Device | Decision |
|---|---|---|
| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | 01/28/1999SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | 12/09/1997SE |
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | 12/04/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | 03/02/1995SE |
| K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeGEI · Traditional | 12/13/1994SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Wells Johnson Fixation System cleared by the FDA?
Wells Johnson Fixation System (K945500) received a 510(k) decision of Substantially Equivalent on September 21, 1995, 316 days after the submission was received.
What is the product code of K945500?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.