GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
FDA 510(k) clearance K110805 · decided 2011-06-21
Clearance details
- K-number
- K110805
- Device name
- GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-23
- Decision date
- 2011-06-21
- Days to decision
- 90 days
- Clearance type
- Special
- Product code
- OBT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lewisville, TX, US
- 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 Plate System Plus (K172183) | Orthofix Srl | 2018-01-09 |
| GUIDED GROWTH SYSTEM (K093442) | Orthofix, Inc. | 2010-06-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CervicalStim® (P030034/S017) | Orthofix, Inc. | 2022-06-14 |
| PhysioStim®, SpinalStim® (P850007/S046) | Orthofix, Inc. | 2022-06-14 |
| SpinalStim (P850007/S044) | Orthofix, Inc. | 2020-03-27 |
| CervicalStim (P030034/S015) | Orthofix, Inc. | 2019-10-08 |
| PhysioStim and SpinalStim (P850007/S043) | Orthofix, Inc. | 2019-10-08 |
| SpinalStim (P850007/S042) | Orthofix, Inc. | 2019-07-03 |
| PhysioStim and SpinalStim (P850007/S041) | Orthofix, Inc. | 2019-06-18 |
| CervicalStim (P030034/S014) | Orthofix, Inc. | 2019-06-18 |