Boundary
GUDID 00810005665186
Buttress Plate Screw 25mm long, 5.5mm circumference, non 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00810005665186 |
| NIH Device Record Key | d59c3350-79d8-4b67-b518-23ab12f8f557 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boundary |
| Version Model Number | ALB-55SC-25 |
| Company DUNS | 047486041 |
| Company Name | NVISION BIOMEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
| Length | 25 Millimeter |
| Circumference | 5.5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810005665186 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173091
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
[00810005665186]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-08-16 |
| Device Publish Date | 2020-11-19 |
On-Brand Devices [Boundary]
| 00814008029808 | Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Bu |
| 00814008025589 | Instrument, Lumbar Buttress Plate Screw Inserter. The Boundary Anterior Lumbar Buttress Plate i |
| 00814008025572 | Instrument, Lumbar Buttress Plate Inserter. The Boundary Anterior Lumbar Buttress Plate is inte |
| 00814008025565 | Instrument, Lumbar Buttress Plate Tap. The Boundary Anterior Lumbar Buttress Plate is intended |
| 00814008025558 | Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intende |
| 00814008025541 | Instrument, Lumbar Buttress Plate Awl. The Boundary Anterior Lumbar Buttress Plate is intended |
| 90814008025537 | Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025520 | Buttress Plate Screw 30mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025513 | Buttress Plate Screw 25mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025506 | Buttress Plate Screw 20mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025490 | Buttress Plate Screw 35mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar |
| 90814008025483 | Buttress Plate Screw 30mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar |
| 90814008025476 | Buttress Plate Screw 25mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar |
| 90814008025469 | Buttress Plate Screw 20mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar |
| 90814008025452 | Buttress Plate Screw 35mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025445 | Buttress Plate Screw 30mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025438 | Buttress Plate Screw 25mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025421 | Buttress Plate Screw 20mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt |
| 90814008025414 | Buttress Plate Screw 35mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar |
| 90814008025407 | Buttress Plate Screw 30mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar |
| 90814008025391 | Buttress Plate Screw 25mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar |
| 90814008025384 | Buttress Plate Screw 20mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar |
| 90814008025377 | Buttress Plate 25mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 90814008025360 | Buttress Plate 25mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 90814008025353 | Buttress Plate 20mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 90814008025346 | Buttress Plate 20mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 90814008025339 | Buttress Plate 15mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 90814008025322 | Buttress Plate 15mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 00810005663908 | Lumbar Buttress Plate INSERT 1 Lid. The Boundary Anterior Lumbar Buttress Plate is intended to |
| 00810005663892 | Lumbar Buttress Plate INSERT 1. The Boundary Anterior Lumbar Buttress Plate is intended to stab |
| 00810005663885 | Lumbar Buttress Plate Case Lid. The Boundary Anterior Lumbar Buttress Plate is intended to stab |
| 00810005663878 | Lumbar Buttress Plate Case Base. The Boundary Anterior Lumbar Buttress Plate is intended to sta |
| 00810005665247 | Buttress Plate Screw 35mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior |
| 00810005665230 | Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior |
| 00810005665223 | Buttress Plate Screw 30mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior |
| 00810005665216 | Buttress Plate Screw 20mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior |
| 00810005665209 | Buttress Plate Screw 35mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante |
| 00810005665193 | Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante |
| 00810005665186 | Buttress Plate Screw 25mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante |
| 00810005665179 | Buttress Plate Screw 20mm long, 5.5mm circumference, non locking, cancellous. The Boundary Ante |
Trademark Results [Boundary]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOUNDARY 98027757 not registered Live/Pending |
Ross Larson 2023-06-05 |
 BOUNDARY 97919006 not registered Live/Pending |
Boundary Digital, LLC 2023-05-03 |
 BOUNDARY 90209468 not registered Live/Pending |
Surgical Scalpels Technology (Shenzhen)Co., Ltd. 2020-09-25 |
 BOUNDARY 88878895 not registered Live/Pending |
Springfield, Inc. 2020-04-20 |
 BOUNDARY 88424905 not registered Live/Pending |
Boundary LLC 2019-05-10 |
 BOUNDARY 88402964 not registered Live/Pending |
JS Products, Inc. 2019-04-25 |
 BOUNDARY 88402656 5896768 Live/Registered |
Boundary Companies LLC 2019-04-25 |
 BOUNDARY 87774117 5629412 Live/Registered |
NVision BioMedical Technologies, LLC 2018-01-29 |
 BOUNDARY 87655521 not registered Dead/Abandoned |
JDTMK LLC 2017-10-23 |
 BOUNDARY 87076859 not registered Dead/Abandoned |
Ironstrike, LLC 2016-06-20 |
 BOUNDARY 87055796 not registered Dead/Abandoned |
Ironstrike, LLC 2016-06-01 |
 BOUNDARY 86908242 5048979 Live/Registered |
CI, LLC 2016-02-15 |
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