Identity
- Trade Name
- WOLF Plate, 122mm, 9 Hole FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses. FDA UDI
Identifiers
- Catalog Number
- TO-LBP-122 FDA UDI
- Primary DI / UDI-DI
- 00816101011957 FDA UDI
- 510(k) Number
- K131834 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Orthopaedic fixation plate, non-bioabsorbable
WOLF Plate, 122mm, 9 Hole by Toby Orthopaedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K131834 also covers:
- WOLF Curved Low Profile Plate, 174mm, 13 Hole — TOBY ORTHOPAEDICS
- WOLF Curved Low Profile Plate, 200mm, 15 Hole — TOBY ORTHOPAEDICS
- WOLF Curved Low Profile Plate, 226mm, 17 Hole — TOBY ORTHOPAEDICS
- WOLF Low Profile Plate, 122mm, 9 Hole — TOBY ORTHOPAEDICS
- WOLF Low Profile Plate, 148mm, 11 Hole — TOBY ORTHOPAEDICS
- WOLF Low Profile Plate, 70mm, 5 Hole — TOBY ORTHOPAEDICS
- WOLF Low Profile Plate, 96mm, 7 Hole — TOBY ORTHOPAEDICS
- WOLF Plate, 148mm, 11 Hole — TOBY ORTHOPAEDICS
- WOLF Plate, 174mm, 13 Hole — TOBY ORTHOPAEDICS
- WOLF Plate, 200mm, 15 Hole — TOBY ORTHOPAEDICS
- WOLF Plate, 226mm, 17 Hole — TOBY ORTHOPAEDICS
- WOLF Plate, 252mm, 19 Hole — TOBY ORTHOPAEDICS
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
- Toby Orthopaedics
Sources (1)
- FDA UDI 54d9be70-f43b-4363-8df6-ad5b6e5bf142 36 fields · synced May 31, 2026