Identity
- Trade Name
- Boundary FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Buttress Plate 25mm long, 8 degree. 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
- AL-BUT-258 FDA UDI
- Description
- Buttress Plate 25mm long, 8 degree. 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
- 90814008025360 FDA UDI
- 510(k) Number
- K173091 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 15 Millimeter FDA UDILength — 25 Millimeter FDA UDIAngle — 8 degree FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Boundary by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal fixation plate, non-bioabsorbable.
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- TSLP — Synthes · Class II
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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 aa83a375-2ade-4d4d-bbbd-52f88d016cea 37 fields · synced May 30, 2026