Impact

GUDID 00810135963329

PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Medical ruler, reusable
Primary Device ID00810135963329
NIH Device Record Key76bc1994-b84e-4b1b-96ca-33d0c51eacb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpact
Version Model NumberPP-1001T-CUT4
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810135963329 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


[00810135963329]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-02
Device Publish Date2025-09-24

On-Brand Devices [Impact]

00810135964173Impact PEEK Fusion Nail Case Assembly The Impact PEEK Union Nail System contains 3.0mm - 4.5mm d
00810135963626Fusion-Grade PEEK Nail 4.0x50mm. The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diam
00810135963619Fusion-Grade PEEK Nail 3.0x50mm. The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diame
00810135963381PEEK Nail 2.0mm extraction drill. The Impact PEEK Union Nail System is indicated for maintenanc
00810135963275PEEK Nail Cannulated 4.0mm drill. The Impact PEEK Union Nail System is indicated for maintenanc
00810135963251PEEK Nail Cannulated 3.0mm drill. The Impact PEEK Union Nail System is indicated for maintenanc
00810135963183Impact PEEK Union Nail 4.0 Inserter Shaft/PEEK Union Nail 4.0mm Inserter Sleeve The Impact PEEK
00810135963169Impact PEEK Union Nail 3.0 Inserter Shaft/PEEK Union Nail3.0mm Inserter Sleeve The Impact PEEK U
00810135963343PEEK Nail 4.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alig
00810135963336PEEK Nail 3.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alig
00810135963657Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation
00810135963640Kwire 1.4mmx127mm single trocar The Impact PEEK Union Nail System is indicated for maintenance o
00810135963411PEEK Nail Slap Hammer The Impact PEEK Union Nail System is indicated for maintenance of alignmen
00810135963404Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment an
00810135963374PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignme
00810135963329PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignme
00810135963282PEEK Union Nail 4.0 Countersink Shaft The Impact PEEK Union Nail System is indicated for mainten
00810135963268PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for mainten

Trademark Results [Impact]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPACT
IMPACT
98601500 not registered Live/Pending
Marli J. Washington
2024-06-14
IMPACT
IMPACT
98528216 not registered Live/Pending
L'Chef, LLC
2024-04-30
IMPACT
IMPACT
98528203 not registered Live/Pending
L'Chef, LLC
2024-04-30
IMPACT
IMPACT
98502001 not registered Live/Pending
Hornady Manufacturing Company
2024-04-16
IMPACT
IMPACT
98384931 not registered Live/Pending
HCMP, Inc.
2024-01-31
IMPACT
IMPACT
98328305 not registered Live/Pending
The Impact Fund
2023-12-22
IMPACT
IMPACT
98328269 not registered Live/Pending
Indian American Impact
2023-12-22
IMPACT
IMPACT
98299820 not registered Live/Pending
NOBULL, LLC
2023-12-05
IMPACT
IMPACT
98285346 not registered Live/Pending
Lazarex Cancer Foundation
2023-11-26
IMPACT
IMPACT
98277080 not registered Live/Pending
Montage Hotels & Resorts, LLC
2023-11-19
IMPACT
IMPACT
98189133 not registered Live/Pending
Alveo Technologies Inc.
2023-09-20
IMPACT
IMPACT
98090236 not registered Live/Pending
MedTech Global Products LLC
2023-07-18

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.