Identity
- Trade Name
- neoWave LS FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- BAYONETTED OSTEOTOME - 1/4" FDA UDI
- Model / Reference
- 23-K01-0800 FDA UDI
- Description
- BAYONETTED OSTEOTOME - 1/4" FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00818345023857 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
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
Category: Orthopaedic osteotome
neoWave LS by Xenix Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182210 also covers:
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- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
- TiWAVE L Lumbar Cage System — Kalitec Direct LLC
K222988 also covers:
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
- Ti3D CERVICAL — Xenix Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xenix Medical
Sources (1)
- FDA UDI 69a54aab-2b96-4024-8b0a-cd7879f3e5a5 36 fields · synced Jun 8, 2026