Spine System Sacral Plate
FDA 510(k) K953881 · J.B.S., S.A.
510(k) numberK953881
Submission
- Device name
- Spine System Sacral Plate
- Applicant
- J.B.S., S.A.
Pleasenton, CA, US - Received
- August 18, 1995
- Decision date
- February 21, 1996
- 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
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| 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 |
| 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 |
| K935113 | J.B.S. Implantable Spinal Fixation DeviceKWP · Traditional | 10/19/1994SE |
Questions and answers
When was Spine System Sacral Plate cleared by the FDA?
Spine System Sacral Plate (K953881) received a 510(k) decision of Substantially Equivalent for Some Indications on February 21, 1996, 187 days after the submission was received.
What is the product code of K953881?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.