FDA.reportPublic FDA data

SafetyFix Easy Out

Primary DI
00853785008163
Brand
SafetyFix Easy Out
Company
Safetyfix Medical Technologies
Model
2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN
Catalog number
22761-0001-1.9-14
Device description
2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LENGTH 14
Published
2018-05-08
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180753000SafetyFix EasyOut SystemSafetyfix Medical Technologies, Inc.2018-04-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853785008163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853785008163008537850081638537850081630853785008163

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter
Outer Diameter2.5Millimeter

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
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
00853785008224SafetyFix Easy Out2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LEN22761-0001-1.9-262018-05-08

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