Identity
- Trade Name
- RIPTIDE FDA UDI
- Generic Name
- Metallic osteotomy fusion cage, non-customized FDA UDI
- Device Name
- Evans Wedge 24x20x11mm FDA UDI
- Model / Reference
- 6ZBZE2411 FDA UDI
- Description
- Evans Wedge 24x20x11mm FDA UDI
Identifiers
- Catalog Number
- 6ZBZE2411 FDA UDI
- Primary DI / UDI-DI
- 00196449002405 FDA UDI
- 510(k) Number
- K150394 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Metallic osteotomy fusion cage, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Metallic osteotomy fusion cage, non-customized
Riptide by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150394 also covers:
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber 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 II | Pending data |
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Manufacturer
- Manufacturer
- Tyber Medical
Sources (1)
- FDA UDI 22d6e0fd-1979-4bcc-99a9-bbba2138b1e9 36 fields · synced Jun 6, 2026