FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDED GROWTH SYSTEM
K Number: K093442
·
Decision Jun 10, 2010
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
57
Review Days
217
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Basic Information
- Device Name
- GUIDED GROWTH SYSTEM
- K Number
- K093442
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix, Inc.
- Date Received
- November 5, 2009
- Decision Date
- June 10, 2010
- Product Code
- OBT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBT), ordered by most recent decision date.
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Guided Growth Plate System Plus
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GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
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FDA Class 2
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Other Clearances by Orthofix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | Jul 30, 2021 | Substantially Equivalent |
| K210667 | FIREBIRD SI Fusion System | Mar 25, 2021 | Substantially Equivalent |
| K203342 | CONSTRUX Mini Ti Spacer System | Mar 18, 2021 | Substantially Equivalent |
| K203576 | FORZA Ti Spacer System | Mar 3, 2021 | Substantially Equivalent |
| K203138 | FIREBIRD SI Fusion System | Nov 18, 2020 | Substantially Equivalent |
| K202949 | CONSTRUX Mini PEEK Spacer System | Oct 29, 2020 | Substantially Equivalent |
| K202666 | CONSTRUX Mini PTC Spacer System | Oct 14, 2020 | Substantially Equivalent |
| K201664 | FIREBIRD SI Fusion System | Sep 15, 2020 | Substantially Equivalent |