510(k) K093442
- Device
- GUIDED GROWTH SYSTEM
- Applicant
- ORTHOFIX INC.
- 510(k) number
- K093442
- Product code
- OBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-10
- Date received
- 2009-11-05
- Regulation
- 888.3030
- Classification name
- Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY BIGGERS
- Address
- 1720 Bray Central Dr. Mckinney TX US 75069 75069
FDA Registration Numbers#
- 3002949614
- 3007539489
- 1828464
- 3006783837
- 9680825
- 1526534
- 3007125392
- 3014314623
- 3005061536
- 1527105
- 3000327445
- 3006460162
- 2183449
- 9611281
- 1824313
- 1828288
- 3009631939
- 3007993775
- 9616944
- 3013680140
- 1834331
Source Documents#
Other 510(k) Records For Product Code OBT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022-10-24 |
| K182704 | WishBone Guided Growth System | Wishbone Medical | 2019-06-25 |
| K180624 | Guided Growth Plate System Plus | Orthofix Srl | 2018-05-15 |
| K172183 | Guided Growth Plate System Plus | Orthofix Srl | 2018-01-09 |
| K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | Orthofix, Inc. | 2011-06-21 |
Legacy Summary#
summary
FDA Review#
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