Identity
- Trade Name
- ORION WEDGE FDA UDI
- Generic Name
- Polymeric osteotomy fusion cage, non-customized FDA UDI
- Device Name
- ORION Ti PEEK EVANS Wedge - 18x18x12mm FDA UDI
- Model / Reference
- HTR-04-184712 FDA UDI
- Description
- ORION Ti PEEK EVANS Wedge - 18x18x12mm FDA UDI
Identifiers
- Catalog Number
- HTR-04-184712 FDA UDI
- Primary DI / UDI-DI
- 00841742124445 FDA UDI
- 510(k) Number
- K150394 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Polymeric 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
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
No
FDA UDI
Category: Polymeric osteotomy fusion cage, non-customized
Orion Wedge by Hnm Total Recon Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polymeric osteotomy fusion cage, non-customized.
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- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class II
- Tarsa Link Bunion — Life Spine, Inc. · Class II
- Tarsa Link Bunion — Life Spine, Inc. · Class II
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class II
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
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hnm Total Recon Llc
Sources (1)
- FDA UDI 73507492-ed4a-4bff-8009-20ad49e80ca8 35 fields · synced Jun 8, 2026