Identity
- Trade Name
- SpineJet® FDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- SpineJet® Microdisectomy Access Set FDA UDI
- Model / Reference
- 56971 FDA UDI
- Description
- SpineJet® Microdisectomy Access Set FDA UDI
Identifiers
- Catalog Number
- 56971 FDA UDI
- Primary DI / UDI-DI
- 00853235007081 FDA UDI
- 510(k) Number
- K002764 FDA UDI
- GMDN Term
- Water jet knife system handpiece, single-use FDA UDI
Classification
- 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
Yes
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. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Water jet knife system handpiece, single-use.
- Versajet — Smith & Nephew Medical, Ltd. · Class II
- Versajet — Smith & Nephew Medical, Ltd. · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- Applikator; gerade — Erbe Elektromedizin GmbH · Class IIb
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hydrocision, Inc.
Sources (1)
- FDA UDI 6a1b73ab-e217-48f3-bb6c-4b4ea06c8c72 35 fields · synced May 31, 2026