Identity
- Trade Name
- Orthex FDA UDI
- Generic Name
- External orthopaedic fixation frame calculation software FDA UDI
- Device Name
- Orthex P&C Software v1.2 FDA UDI
- Model / Reference
- ORTHEXRPS FDA UDI
- Description
- Orthex P&C Software v1.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731118844 FDA UDI
- 510(k) Number
- K151881 FDA UDI
- FDA Product Code
- OSN FDA UDIKTT FDA UDI
- GMDN Term
- External orthopaedic fixation frame calculation software 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External orthopaedic fixation frame calculation software
Orthex by Vilex In Tennessee, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation frame calculation software.
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- MAXFRAME — Synthes · Class II
- Orthex/ Instrument Case — ORTHOPEDIATRICS CORP. · Class I
- MAXFRAME — SYNTHES (U.S.A.) LP · Class II
- Orthex External Fixation System — ORTHOPEDIATRICS CORP. · Class II
- True Lok System — Orthofix, Inc. · Class II
- MAXFRAME — SYNTHES (U.S.A.) LP · Class II
- Orthex/ Instrument Case — ORTHOPEDIATRICS CORP. · Class I
Cleared under the same submission
K151881 also covers:
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Vilex Tool — ORTHOPEDIATRICS CORP.
- Vilex Tool — ORTHOPEDIATRICS CORP.
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
- Vilex In Tennessee, Inc.
Sources (1)
- FDA UDI cb8ce1bc-c86c-4412-b1f2-1edf796f036e 34 fields · synced Jun 1, 2026