JBS Smooth Fixation Pin
FDA 510(k) K940666 · J.B.S., S.A.
510(k) numberK940666
Submission
- Device name
- JBS Smooth Fixation Pin
- Applicant
- J.B.S., S.A.
Foster City, CA, US - Received
- February 16, 1994
- Decision date
- November 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K962757 | J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking…MNH · Traditional | 09/25/1996SE |
| K955864 | J.B. S. C1-C2 ClampKWP · Traditional | 03/15/1996SE |
| K953881 | Spine System Sacral PlateMNH · Traditional | 02/21/1996SN |
| K953599 | Clamp AssemblyKWP · Traditional | 12/19/1995SN |
| K952298 | Spinal Pedicle Screw, Fixation, ApplianceMNH · Traditional | 12/13/1995SN |
| K942432 | J.B.S. Cervical Spine SystemKWP · Traditional | 07/11/1995SN |
| K940673 | J.B.S. Self-Tapping Threaded PinHTY · Traditional | 11/14/1994SE |
| K940669 | J.B.S. B.A.C. PinHTY · Traditional | 11/14/1994SE |
| K935113 | J.B.S. Implantable Spinal Fixation DeviceKWP · Traditional | 10/19/1994SE |
Questions and answers
When was JBS Smooth Fixation Pin cleared by the FDA?
JBS Smooth Fixation Pin (K940666) received a 510(k) decision of Substantially Equivalent on November 14, 1994, 271 days after the submission was received.
What is the product code of K940666?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.