FDA.reportPublic FDA data

SafetyFix Easy Out

Primary DI
00853785008040
Brand
SafetyFix Easy Out
Company
Safetyfix Medical Technologies
Model
Driver
Catalog number
Driver
Device description
Screw Driver for Bone Screws
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141401000EASY OUTFeet For Life Podiatry Center2015-02-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853785008040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853785008040008537850080408537850080400853785008040

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3148800750info@safetyfixmedical.com

Regulatory Flags#

DUNS number
094825235
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853785008002SafetyFix Easy Out2.5 MM CORT BONE SCREW LENGTH 142.5-1.9-142018-01-26
00853785008019SafetyFix Easy Out2.5 MM CORT BONE SCREW LENGTH 162.5-1.9-162018-01-26
00853785008026SafetyFix Easy Out2.5 MM CORT BONE SCREW LENGTH 182.5-1.9-182018-01-26
00853785008057SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-122018-05-08
00853785008064SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-142018-05-08
00853785008071SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-162018-05-08
00853785008088SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-182018-05-08
00853785008095SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-202018-05-08
00853785008101SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-222018-05-08
00853785008118SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-242018-05-08
00853785008125SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-262018-05-08
00853785008132SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-282018-05-08
00853785008149SafetyFix Easy Out2.0MM CANNULATED SCREW, SQUARE DRIVER, 1.9MM HEAD,22761-0003-1.9-302018-05-08
00853785008156SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-122018-05-08
00853785008163SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-142018-05-08
00853785008170SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-162018-05-08
00853785008187SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-182018-05-08
00853785008194SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-202018-05-08
00853785008200SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-222018-05-08
00853785008217SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-242018-05-08

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