Identity
- Trade Name
- Boundary FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications. FDA UDI
- Model / Reference
- BUT-1000T-DRL FDA UDI
- Description
- Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814008025558 FDA UDI
- 510(k) Number
- K173091 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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: General internal orthopaedic fixation system implantation kit
Boundary by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173091 also covers:
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC
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
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 121318fb-7104-4efe-b51a-ac09b58ca1b4 36 fields · synced May 30, 2026