Identity
- Trade Name
- KITE FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- KIT – KITE Malleolar Plate (L) Short FDA UDI
- Model / Reference
- KM2.7109 FDA UDI
- Description
- KIT – KITE Malleolar Plate (L) Short FDA UDI
Identifiers
- Catalog Number
- KM2.7109 FDA UDI
- Primary DI / UDI-DI
- 08056693002021 FDA UDI
- 510(k) Number
- K230623 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 82 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Kite by Intrauma Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K230623 also covers:
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
- CORTICAL SCREW — INTRAUMA SPA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intrauma Spa
Sources (1)
- FDA UDI fd380167-3d32-4bcc-8f0d-998c64b62e54 36 fields · synced Jun 1, 2026