Guided Growth Plate System Plus
FDA 510(k) clearance K172183 · decided 2018-01-09
Clearance details
- K-number
- K172183
- Device name
- Guided Growth Plate System Plus
- Applicant
- Orthofix Srl
- Decision
- Substantially Equivalent
- Date received
- 2017-07-19
- Decision date
- 2018-01-09
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- OBT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bussolengo, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| The GIRO Growth Modulation System (K220190) | Pega Medical, Inc. | 2022-10-24 |
| WishBone Guided Growth System (K182704) | Wishbone Medical | 2019-06-25 |
| Guided Growth Plate System Plus (K180624) | Orthofix Srl | 2018-05-15 |
| GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) (K110805) | Orthofix, Inc. | 2011-06-21 |
| GUIDED GROWTH SYSTEM (K093442) | Orthofix, Inc. | 2010-06-10 |
Recalls involving this device
No recalls on record reference this clearance.