Identity
- Trade Name
- EXPEDIUM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- EXPEDIUM SPINE SYSTEM EXTENDED TAB WIDE HOOK 4.5 x 4.25mm FDA UDI
- Model / Reference
- 186153440 FDA UDI
- Description
- EXPEDIUM SPINE SYSTEM EXTENDED TAB WIDE HOOK 4.5 x 4.25mm FDA UDI
Identifiers
- Catalog Number
- 186153440 FDA UDI
- Primary DI / UDI-DI
- 10705034108230 FDA UDI
- FDA Product Code
- KWQ FDA UDIMNH FDA UDINKB FDA UDIKWP FDA UDIOSH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Bone-screw internal spinal fixation system hook
Expedium by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system hook.
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Cleared under the same submission
K071495 also covers:
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM SFX — Depuy Spine, Inc.
K111136 also covers:
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, Inc.
- EXPEDIUM — Depuy Spine, 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
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 9d2a2579-3455-403c-aaec-41158b3dc83f 36 fields · synced May 30, 2026