Identity
- Trade Name
- Rhausler FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 63MM QUICKPLATE 3LVL FDA UDI
- Model / Reference
- C-3363 FDA UDI
- Description
- 63MM QUICKPLATE 3LVL FDA UDI
Identifiers
- Catalog Number
- C-3363 FDA UDI
- Primary DI / UDI-DI
- 08500588270199 FDA UDI
- 510(k) Number
- K042073 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 63 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Rhausler by Rhausler, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
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- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K042073 also covers:
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, 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
- Rhausler, Inc.
Sources (1)
- FDA UDI 3281a5b5-1891-4b20-885a-27913357989e 36 fields · synced May 30, 2026