Moss Miami Spinal System (Anterior Use)
FDA 510(k) K953915 · Depuy, Inc.
510(k) numberK953915
Submission
- Device name
- Moss Miami Spinal System (Anterior Use)
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- August 21, 1995
- Decision date
- February 15, 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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|---|---|---|---|
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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 Moss Miami Spinal System (Anterior Use) cleared by the FDA?
Moss Miami Spinal System (Anterior Use) (K953915) received a 510(k) decision of Substantially Equivalent for Some Indications on February 15, 1996, 178 days after the submission was received.
What is the product code of K953915?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.