Identity
- Trade Name
- GUIDED GROWTH PLATE SYSTEM FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Device Name
- CANNULATED DRILL BIT D2.4MM WITH QUICK CONNECT FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- CANNULATED DRILL BIT D2.4MM WITH QUICK CONNECT FDA UDI
Identifiers
- Catalog Number
- 180010 FDA UDI
- Primary DI / UDI-DI
- 18054242518037 FDA UDI
- 510(k) Number
- K172698 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, non-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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.4 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use, non-sterile
Guided Growth Plate System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, single-use, non-sterile.
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- CURE ACP — MEDITECH SPINE, LLC · Class II
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- XtraFix® — Zimmer, Inc. · Class I
- CALIBRATED DRILL BIT — Biomet Orthopedics, Inc. · Class I
- AFT™ Proximal Humerus Fracture Plate System — Shoulder Options, Inc. · Class II
- SOLID DRILL — Biomet Orthopedics, Inc. · Class I
- S³F.A.S.T. DRILL BIT, STEP — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K172698 also covers:
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming 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 2adbb3b6-7223-4013-98bc-438071ca4526 37 fields · synced Jun 1, 2026