Synergy(Tm) Ti Posterior Spinal System
FDA 510(k) K950099 · Buckman Co., Inc.
510(k) numberK950099
Submission
- Device name
- Synergy(Tm) Ti Posterior Spinal System
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- January 10, 1995
- Decision date
- January 16, 1997
- 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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| 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 |
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Questions and answers
When was Synergy(Tm) Ti Posterior Spinal System cleared by the FDA?
Synergy(Tm) Ti Posterior Spinal System (K950099) received a 510(k) decision of Substantially Equivalent for Some Indications on January 16, 1997, 737 days after the submission was received.
What is the product code of K950099?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.