FDA.reportPublic FDA data

Power Dental USA

Primary DI
D94378030
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
7803
Catalog number
7803
Device description
POWER LATERAL APPROACH KIT
Published
2021-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWDSTARTER, BONE SCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWDStarter, Bone ScrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D94378030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@powerdentalgroup.com

Regulatory Flags#

DUNS number
081305064
Device count
1
Premarket exempt
true
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731134752Hintermann Series VILEX LLCHWD2025-09-17
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00840180529270General InstrumentsALPHATEC SPINE, INC.HWD2024-08-01
B07315K0140200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
B07315K0160200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
00887868570940Distal Screw SheathBiomet Orthopedics, LLCHWD2023-08-15
00887868570049Distal ScrewBiomet Orthopedics, LLCHWD2023-06-13
00887868570124Lag Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570148Affixus®Biomet Orthopedics, LLCHWD2023-06-13
00887868570155Anti-Rotation Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570162Anti-Rotation Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570179Anti-Rotation Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570186Lag Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570193Lag Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570230Lag Screw TapBiomet Orthopedics, LLCHWD2023-06-13
00887868570247Distal Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00844856069756ArsenalALPHATEC SPINE, INC.HWD2023-05-13
00190376477954AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477961AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477978AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477985AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00885556864869Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864876Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864883Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864890Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864906Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
04026575182572LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-27
04026575046768Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-20
04026575395521SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-16
04026575347698LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-15