FDA.reportPublic FDA data

NEONAIL

Primary DI
07898624869669
Brand
NEONAIL
Company
Neoortho Produtos Ortopédicos S/A.
Model
936.227
Device description
Femur Nail D14x460 mm
Published
2015-10-21
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141103000INTRAMEDULLARY NAIL AND SCREWS-NEONAILNeoortho Produtos Ortopedicos S/A2014-09-23HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898624869669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898624869669078986248696697898624869669

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, non-sterileA non-sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. 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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