Boundary
- Primary DI
- 00814008025541
- Brand
- Boundary
- Company
- NVision Biomedical Technologies, Inc.
- Model
- BUT-1000T-AWL
- Device description
- Instrument, Lumbar Buttress Plate Awl. 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
- 2018-07-11
- 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 |
|---|---|---|---|---|
| 00814008025541 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00814008025541 | 00814008025541 | 814008025541 | 0814008025541 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bone awl, reusable | A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device. |
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
- false
- 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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|---|---|---|---|---|
| 00810135961264 | Toejack | TJB-1001T-SG05 | 2026-07-24 | |
| 00810135961271 | Toejack | TJB-1000T-JBCG | 2026-07-24 | |
| 00810135961752 | Toejack | TJB-1000T-PDS | 2026-07-24 | |
| 00810005666855 | Trigon | LD-050004T-28 | 2024-02-22 | |
| 00810005666862 | Trigon | LD-050006T-28 | 2024-02-22 | |
| 00810005666985 | Trigon | LDP-2408-0410 | 2024-02-22 | |
| 00810005666992 | Trigon | LDP-2408-0408 | 2024-02-22 | |
| 00810005667005 | Trigon | LDP-2408-0406 | 2024-02-22 | |
| 00810005667012 | Trigon | LDP-2408-0404 | 2024-02-22 | |
| 00810005667029 | Trigon | LDP-2408-0210 | 2024-02-22 | |
| 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 | |
| 00810005667111 | Trigon | LDP-2405-0406 | 2024-02-22 | |
| 00810005667128 | Trigon | LDP-2405-0404 | 2024-02-22 |
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