Identity
- Trade Name
- K-Wire Depth Gauge, 1.1mm FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- K-Wire Depth Gauge, 1.1mm FDA UDI
- Model / Reference
- WG11 FDA UDI
- Description
- K-Wire Depth Gauge, 1.1mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810054093503 FDA UDI
- 510(k) Number
- K222967 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical depth gauge, 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
Category: Surgical depth gauge, reusable
K-Wire Depth Gauge, 1.1mm by Avanti Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
- Depth Gauge — I.T.S. GmbH · Class I
- FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
- FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Cleared under the same submission
K222967 also covers:
- Cannulated Compression Screw System Caddy, 3.2mm and 4.0mm — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 16mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 20mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 22mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 26mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 28mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 34mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 36mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.7mm x 14mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.7mm x 16mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.7mm x 18mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Compression Screw w/ Hexalobular Drive, 2.7mm x 22mm Long — AVANTI ORTHOPAEDICS LLC
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
- Avanti Orthopaedics Llc
Sources (1)
- FDA UDI fa4c98e7-eb47-4016-9e8e-dbcb9a6ce018 35 fields · synced Jun 8, 2026