Polaris Spinal Growth System
FDA 510(k) K180227 · Zimmer Biomet Spine, Inc.
510(k) numberK180227
Submission
- Device name
- Polaris Spinal Growth System
- Applicant
- Zimmer Biomet Spine, Inc.
Westminister, CO, US - Received
- January 26, 2018
- Decision date
- March 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGM – Growing Rod System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Stabilization or correction of spinal deformities without the use of fusion.
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| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | Stryker Corporation | 10/27/2014SE |
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| K190556 | Zimmer Biomet Universal Navigation SystemOLO · Traditional | 10/24/2019SE |
| K183550 | Vitality® Spinal Fixation SystemNKB · Traditional | 04/08/2019SE |
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Questions and answers
When was Polaris Spinal Growth System cleared by the FDA?
Polaris Spinal Growth System (K180227) received a 510(k) decision of Substantially Equivalent on March 15, 2018, 48 days after the submission was received.
What is the product code of K180227?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.