Identity
- Trade Name
- CONTOURS LAPIDUS PLATING SYSTEM FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- TAP SLEEVE FOR 2.5MM AND 3.5MM DRILL BITS FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TAP SLEEVE FOR 2.5MM AND 3.5MM DRILL BITS FDA UDI
Identifiers
- Catalog Number
- DH0469 FDA UDI
- Primary DI / UDI-DI
- 18054242514251 FDA UDI
- 510(k) Number
- K102201 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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
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
- Width — 213 Millimeter FDA UDI
Category: Surgical drill guide, reusable
Contours Lapidus Plating System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K102201 also covers:
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — Orthofix, Inc.
- CONTOURS LAPIDUS PLATING SYSTEM — 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 b4a41e69-f7b9-45ee-95c3-ec4cdf6ab54d 37 fields · synced May 30, 2026