Identity
- Trade Name
- DRILL PT GUIDE WIRE FDA UDI
- Generic Name
- Internal orthopaedic fixation system, cerclage wire/cable, sterile FDA UDI
- Model / Reference
- 469360 FDA UDI
Identifiers
- Catalog Number
- 469360 FDA UDI
- Primary DI / UDI-DI
- 00880304382367 FDA UDI
- 510(k) Number
- K831005 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, cerclage wire/cable, sterile 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Internal orthopaedic fixation system, cerclage wire/cable, sterile
Drill Pt Guide Wire by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Internal orthopaedic fixation system, cerclage wire/cable, sterile.
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- LIGAPASS — Medicrea International SA · Class II
- LIGAPASS — Medicrea International SA · Class II
- LIGAPASS — Medicrea International SA · Class II
Cleared under the same submission
K831005 also covers:
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- .062 X 8" GUIDE WIRE — Biomet Orthopedics, Inc.
- .062" DIA X 8" LONG — Biomet Orthopedics, Inc.
- 1.6MM X 150MM GUIDE WIRE — Biomet Orthopedics, Inc.
- 2.0MM X 250MM NON THD GUIDE WIRE — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI d11bbcd1-f795-454b-8790-db00536542f8 36 fields · synced May 30, 2026