Identity
- Trade Name
- PROCALLUS FIXATOR FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- DRILL GUIDE DIAMETER 4.8 MM LENGTH 140 MM FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- DRILL GUIDE DIAMETER 4.8 MM LENGTH 140 MM FDA UDI
Identifiers
- Catalog Number
- 11125 FDA UDI
- Primary DI / UDI-DI
- 18032568032352 FDA UDI
- 510(k) Number
- K955848 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Dimensions & Sizes
- Size
- Outer Diameter — 4.8 Millimeter FDA UDILength — 140 Millimeter FDA UDI
Category: Surgical drill guide, reusable
Procallus Fixator by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, reusable.
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Cleared under the same submission
K955848 also covers:
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, 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 |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 3e420dc4-0e7a-4ee7-b32b-37fc0a8e84ff 37 fields · synced May 30, 2026