J.B.S. Implantable Spinal Fixation Device
FDA 510(k) K935113 · J.B.S., S.A.
510(k) numberK935113
Submission
- Device name
- J.B.S. Implantable Spinal Fixation Device
- Applicant
- J.B.S., S.A.
Foster City, CA, US - Received
- October 25, 1993
- Decision date
- October 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 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 |
| K940666 | JBS Smooth Fixation PinHTY · Traditional | 11/14/1994SE |
Questions and answers
When was J.B.S. Implantable Spinal Fixation Device cleared by the FDA?
J.B.S. Implantable Spinal Fixation Device (K935113) received a 510(k) decision of Substantially Equivalent on October 19, 1994, 359 days after the submission was received.
What is the product code of K935113?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.