Boundary
- Primary DI
- 00814008029808
- Brand
- Boundary
- Company
- NVision Biomedical Technologies, Inc.
- Model
- BUT-1000T-500
- Device description
- Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. 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.
- Published
- 2018-11-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K173091 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00814008029808 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00814008029808 | 00814008029808 | 814008029808 | 0814008029808 |
GMDN Terms#
| Term | Definition |
|---|---|
| Spinal fixation plate, non-bioabsorbable | A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| 210-545-3713 | diana@nvisionbiomed.com |
Regulatory Flags#
- DUNS number
- 047486041
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 00810005666862 | Trigon | LD-050006T-28 | 2024-02-22 | |
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| 00810005666992 | Trigon | LDP-2408-0408 | 2024-02-22 | |
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| 00810005667036 | Trigon | LDP-2408-0208 | 2024-02-22 | |
| 00810005667043 | Trigon | LDP-2408-0206 | 2024-02-22 | |
| 00810005667050 | Trigon | LDP-2408-0204 | 2024-02-22 | |
| 00810005667067 | Trigon | LDP-2408-0010 | 2024-02-22 | |
| 00810005667074 | Trigon | LDP-2408-0008 | 2024-02-22 | |
| 00810005667081 | Trigon | LDP-2408-0006 | 2024-02-22 | |
| 00810005667098 | Trigon | LDP-2408-0004 | 2024-02-22 | |
| 00810005667104 | Trigon | LDP-2405-0408 | 2024-02-22 | |
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