Identity
- Trade Name
- GIRO GROWTH MODULATION SYSTEM FDA UDI
- Generic Name
- Growth-correction orthopaedic fixation plate kit FDA UDI
- Device Name
- EMPTY GIRO IMPLANT CASE 6.0 FDA UDI
- Model / Reference
- GRO-IME100-60 FDA UDI
- Description
- EMPTY GIRO IMPLANT CASE 6.0 FDA UDI
Identifiers
- Catalog Number
- GRO-IME100-60 FDA UDI
- Primary DI / UDI-DI
- 07540194013705 FDA UDI
- 510(k) Number
- K220190 FDA UDI
- FDA Product Code
- HWC FDA UDIOBT FDA UDI
- GMDN Term
- Growth-correction orthopaedic fixation plate kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Growth-correction orthopaedic fixation plate kit
Giro Growth Modulation System by Orthopediatrics Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Growth-correction orthopaedic fixation plate kit.
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- PROVIEW — Orthofix US LLC · Class I
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Cleared under the same submission
K220190 also covers:
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (1)
- FDA UDI afe10393-f3ec-4e6b-ab4e-35918909c71e 37 fields · synced Jun 1, 2026