Identity
- Trade Name
- P-tanium Wedge FDA UDI
- Generic Name
- Polymeric osteotomy fusion cage, non-customized FDA UDI
- Device Name
- Wedge TYPEEK Cotton - 20mm x 6.5mm FDA UDI
- Model / Reference
- TOCOTW197P-S FDA UDI
- Description
- Wedge TYPEEK Cotton - 20mm x 6.5mm FDA UDI
Identifiers
- Catalog Number
- TOCOTW197P-S FDA UDI
- Primary DI / UDI-DI
- M695TOCOTW197PS0 FDA UDI
- 510(k) Number
- K150394 FDA UDI
- FDA Product Code
- HRS FDA UDIPLF FDA UDIHWC FDA UDI
- GMDN Term
- Polymeric osteotomy fusion cage, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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: Polymeric osteotomy fusion cage, non-customized
P-tanium Wedge by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric osteotomy fusion cage, non-customized.
- Tarsa-Link Wedge Fixation System — Life Spine, Inc. · Class II
- Tarsa Link Bunion — Life Spine, Inc. · Class II
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class II
- Tarsa-Link Wedge Fixation System — Life Spine, Inc. · Class II
- 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
- 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 e1ed699d-ca8a-45a6-a9d7-589d582344d8 36 fields · synced May 30, 2026