Spinal Concepts, Inc., Bacfix Ti Spinal Fixation System
FDA 510(k) K973687 · Spinal Concepts, Inc.
510(k) numberK973687
Submission
- Device name
- Spinal Concepts, Inc., Bacfix Ti Spinal Fixation System
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- September 26, 1997
- Decision date
- March 18, 1998
- 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 Spinal Concepts, Inc., Bacfix Ti Spinal Fixation System cleared by the FDA?
Spinal Concepts, Inc., Bacfix Ti Spinal Fixation System (K973687) received a 510(k) decision of Substantially Equivalent for Some Indications on March 18, 1998, 173 days after the submission was received.
What is the product code of K973687?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.