FDA.reportPublic FDA data

NEOFIX

Primary DI
07898624863247
Brand
NEOFIX
Company
Neoortho Produtos Ortopédicos S/A.
Model
901.190
Device description
Star Head Cap Screw Ø 5 mm
Published
2015-09-29
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
K113733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113733000SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIXNeoortho Produtos Ortopedicos S/A2012-03-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898624863247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898624863247078986248632477898624863247

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate bending insert, single-useA non-sterile device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head used solely during the bending of plates that typically have a continuous row of screw holes. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+554135351000sac@neoortho.com.br

Regulatory Flags#

DUNS number
914644351
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899893203253NEONAIL932.2002015-10-07
07899893203260NEONAIL932.2012015-10-07
07899893203277NEONAIL932.2022015-10-07
07899893203284NEONAIL932.2102015-10-07
07899893203291NEONAIL933.5002015-10-07
07899893203307NEONAIL934.9002015-10-07
07899893203314NEONAIL934.9012015-10-07
07899893203321NEONAIL934.9022015-10-07
07899893203338NEONAIL934.9032015-10-07
07899893203345NEONAIL934.9042015-10-07
07899893203352NEONAIL934.9052015-10-07
07899893203369NEONAIL934.9062015-10-07
07899893203376NEONAIL934.9072015-10-07
07898624867580NEOPLATE942.6002015-09-25
07898624867597NEOPLATE942.6012015-09-25
07898624867603NEOPLATE942.6022015-09-25
07898624867610NEOPLATE942.6032015-09-25
07898624867627NEOPLATE942.6042015-09-25
07898624867634NEOPLATE942.6052015-09-25
07898624867641NEOPLATE942.6062015-09-25

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Primary DI, Brand, Company table
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00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
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