PGMClass II
Growing Rod System
21 CFR 888.3070 / Orthopedic
PGM is the FDA product code for Growing Rod System, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "Stabilization or correction of spinal deformities without the use of fusion". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PGM
- Device name
- Growing Rod System
- FDA definition
- Stabilization or correction of spinal deformities without the use of fusion.
- Regulation
- 21 CFR 888.3070
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 14
- Ingested recalls
- 0
Clearances, product code PGM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 4 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code PGM| Applicant | Clearances |
|---|---|
| Globus Medical, Inc. | 2 |
| Medtronic Sofamor Danek USA Inc | 2 |
| Baat Medical Products B.V. | 1 |
| K2M, Inc | 1 |
| Medos International SARL | 1 |
| Medos SARL | 1 |
| Medtronic Sofamor Danek USA, Incorporated | 1 |
| Nu Vasive, Incorporated | 1 |
| Orthopediatrics Corp | 1 |
| SeaSpine Orthopedics Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.