Identity
- Trade Name
- SpineJet® FDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- SpineJet® 20° XLS-OVAL FDA UDI
- Model / Reference
- 57162 FDA UDI
- Description
- SpineJet® 20° XLS-OVAL FDA UDI
Identifiers
- Catalog Number
- 57162 FDA UDI
- Primary DI / UDI-DI
- 00853235007111 FDA UDI
- 510(k) Number
- K002764 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Water jet knife system handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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
Yes
FDA UDI
Category: Water jet knife system handpiece, single-use
SpineJet® by Hydrocision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002764 also covers:
- Allograft — HYDROCISION, INC.
- Allograft-ALT — HYDROCISION, INC.
- Cannula — HYDROCISION, INC.
- HydroCision Console — HYDROCISION, INC.
- HydroCision Console — HYDROCISION, INC.
- Knob — HYDROCISION, INC.
- QuickKart Procedure Cart — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, INC.
- SpineJet® — HYDROCISION, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hydrocision, Inc.
Sources (1)
- FDA UDI 314f2693-3346-4b4c-9a35-36e029067ffa 35 fields · synced Jun 6, 2026