J.B.S. Cervical Spine System
FDA 510(k) K942432 · J.B.S., S.A.
510(k) numberK942432
Submission
- Device name
- J.B.S. Cervical Spine System
- Applicant
- J.B.S., S.A.
Foster City, CA, US - Received
- May 20, 1994
- Decision date
- July 11, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| 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 |
| K935113 | J.B.S. Implantable Spinal Fixation DeviceKWP · Traditional | 10/19/1994SE |
Questions and answers
When was J.B.S. Cervical Spine System cleared by the FDA?
J.B.S. Cervical Spine System (K942432) received a 510(k) decision of Substantially Equivalent for Some Indications on July 11, 1995, 417 days after the submission was received.
What is the product code of K942432?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.