Identity
- Trade Name
- Palisade Pedicular Fixation System FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Rasp FDA UDI
- Model / Reference
- 67-19-07 FDA UDI
- Description
- Rasp FDA UDI
Identifiers
- Catalog Number
- 671-0061 FDA UDI
- Primary DI / UDI-DI
- M7406710061 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Category: Orthopaedic osteotome
Palisade Pedicular Fixation System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome.
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- Symmetry Lambotte — SYMMETRY SURGICAL INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI cb35b4dc-9117-43a6-aeef-4ab582bcd83e 35 fields · synced Jun 1, 2026