Identity
- Trade Name
- X-PAC FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Torque-Limiting Handle (4in/lb) FDA UDI
- Model / Reference
- EI3205 FDA UDI
- Description
- Torque-Limiting Handle (4in/lb) FDA UDI
Identifiers
- Catalog Number
- EI3205 FDA UDI
- Primary DI / UDI-DI
- 00850041805849 FDA UDI
- 510(k) Number
- K250602 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
Yes
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: General internal orthopaedic fixation system implantation kit
X-Pac by Expanding Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
K250602 also covers:
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
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
- Expanding Innovations, Inc.
Sources (1)
- FDA UDI 47f4729e-f355-4e74-9787-1ff772846dd7 36 fields · synced Jun 8, 2026