Identity
- Trade Name
- Boundary FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. 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
- ALB-55LC-25 FDA UDI
- Description
- Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. 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
- 00810005665230 FDA UDI
- 510(k) Number
- K173091 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal bone screw, 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
- Length — 25 Millimeter FDA UDICircumference — 5.5 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Boundary by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 39409a82-34dc-4386-ac74-ea61c42414ce 37 fields · synced May 30, 2026