Wright Medical Technology Rod-To-Rod Coupler
FDA 510(k) K980496 · Wrightmedicaltechnologyinc
510(k) numberK980496
Submission
- Device name
- Wright Medical Technology Rod-To-Rod Coupler
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- February 9, 1998
- Decision date
- April 14, 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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| 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 |
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Questions and answers
When was Wright Medical Technology Rod-To-Rod Coupler cleared by the FDA?
Wright Medical Technology Rod-To-Rod Coupler (K980496) received a 510(k) decision of Substantially Equivalent for Some Indications on April 14, 1998, 64 days after the submission was received.
What is the product code of K980496?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.