Trinity Polyaxial Screw, Mehdian Spinal Rod (6MM), Model 159.XXX Series Catalogue Numbers
FDA 510(k) K010776 · Corin USA
510(k) numberK010776
Submission
- Device name
- Trinity Polyaxial Screw, Mehdian Spinal Rod (6MM), Model 159.XXX Series Catalogue Numbers
- Applicant
- Corin USA
Tampa, FL, US - Received
- March 14, 2001
- Decision date
- April 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| 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 |
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Questions and answers
When was Trinity Polyaxial Screw, Mehdian Spinal Rod (6MM), Model 159.XXX Series Catalogue Numbers cleared by the FDA?
Trinity Polyaxial Screw, Mehdian Spinal Rod (6MM), Model 159.XXX Series Catalogue Numbers (K010776) received a 510(k) decision of Substantially Equivalent on April 6, 2001, 23 days after the submission was received.
What is the product code of K010776?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.