FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
The GIRO Growth Modulation System
K Number: K220190
·
Decision Oct 24, 2022
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
12
Review Days
273
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Basic Information
- Device Name
- The GIRO Growth Modulation System
- K Number
- K220190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pega Medical, Inc.
- Date Received
- January 24, 2022
- Decision Date
- October 24, 2022
- 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
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Other Clearances by Pega Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211292 | Fassier-Duval Telescopic IM System | May 26, 2021 | Substantially Equivalent |
| K192710 | The Simple Locking Intramedullary (Slim) System | Jun 24, 2020 | Substantially Equivalent |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Sep 8, 2017 | Substantially Equivalent |
| K163003 | Y3 Proximal Femoral Plate System | Mar 16, 2017 | Substantially Equivalent |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | Nov 23, 2016 | Substantially Equivalent |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | Jul 10, 2015 | Substantially Equivalent |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | Nov 27, 2013 | Substantially Equivalent |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | Jan 26, 2012 | Substantially Equivalent |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | May 20, 2009 | Substantially Equivalent |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | Aug 17, 2004 | Substantially Equivalent |