Identity
- Trade Name
- Summa Orthopaedics System Surgical Instrument FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Model / Reference
- SO-111-362 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800089466177 FDA UDI
- 510(k) Number
- K242247 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic implant aiming arm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant aiming arm
Summa Orthopaedics System Surgical Instrument by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant aiming arm.
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Cleared under the same submission
K242247 also covers:
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
- ARIX Femur Nail System — Jeil Medical Corporation
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
- Jeil Medical Corporation
Sources (1)
- FDA UDI cadb852b-8391-460b-9104-e8969f623e6a 33 fields · synced Jun 1, 2026