FDA.reportPublic FDA data

CALCANEA

Primary DI
10381780048398
Brand
CALCANEA
Company
NEWDEAL
Model
180335ND
Catalog number
180335ND
Device description
The CALCANEA locking screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They are threaded heads adapted to the threaded holes of the plate. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface.
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041786000CALCAMEA PLATENew Deal, S.A.2004-09-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780048398PrimaryGS10
M248180335ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004839810381780048398

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterile"A 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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10381780126539TIBIAXYS®159985ND2017-05-26
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