FDA.reportPublic FDA data

TRUFIX Bone Fixation System

Primary DI
00614950005918
Brand
TRUFIX Bone Fixation System
Company
ACE SURGICAL SUPPLY CO., INC.
Model
45423003
Catalog number
45423003
Device description
SELF DRILL BONE SCREWS 5/PKG 1.25MM SPLINE 4HD 2.7TD 12TL TI
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OATImplant, endosseous, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951392000MINIBONEPLATE SYSTEMAce Surgical Supply Co., Inc.1995-05-05JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10614950005915PackageGS15In Commercial Distribution
00614950005918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061495000591510614950005915
00614950005918006149500059186149500059180614950005918

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873099689BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100279BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100286BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100354BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100361BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100378BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100385BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873093021BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873098736BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099580BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099597BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099603BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099610BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099627BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099634BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099641BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12