Spinal Pedicle Screw, Fixation, Appliance
FDA 510(k) K952298 · J.B.S., S.A.
510(k) numberK952298
Submission
- Device name
- Spinal Pedicle Screw, Fixation, Appliance
- Applicant
- J.B.S., S.A.
Foster City, CA, US - Received
- May 16, 1995
- Decision date
- December 13, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
More from Spineart
| 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 |
| 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 |
| K935113 | J.B.S. Implantable Spinal Fixation DeviceKWP · Traditional | 10/19/1994SE |
Questions and answers
When was Spinal Pedicle Screw, Fixation, Appliance cleared by the FDA?
Spinal Pedicle Screw, Fixation, Appliance (K952298) received a 510(k) decision of Substantially Equivalent for Some Indications on December 13, 1995, 211 days after the submission was received.
What is the product code of K952298?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.