FDA.reportPublic FDA data

NA

Primary DI
04042409205200
Brand
NA
Company
aap Implantate AG
Model
SK 3512-45-2
Catalog number
SK 3512-45-2
Device description
Cortical Screw 3.5, small head, self-tapping, L 45
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K113652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113652000LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF TAap Implantate AG2012-08-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409205200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409205200040424092052004042409205200

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042409200021NASC 4030-46-2SC 4030-46-22016-08-18
04042409200038NASC 4030-48-2SC 4030-48-22016-08-18
04042409200045NASC 4030-50-2SC 4030-50-22016-08-18
04042409200076NASC 4050-10-2SC 4050-10-22016-08-18
04042409200083NASC 4050-12-2SC 4050-12-22016-08-18
04042409200090NASC 4050-14-2SC 4050-14-22016-08-18
04042409200106NASC 4050-16-2SC 4050-16-22016-08-18
04042409200120NASC 4050-18-2SC 4050-18-22016-08-18
04042409200151NASC 4050-20-2SC 4050-20-22016-08-18
04042409200168NASC 4050-22-2SC 4050-22-22016-08-18
04042409236990NASC 4030-46SC 4030-462016-08-18
04042409237003NASC 4030-48SC 4030-482016-08-18
04042409237010NASC 4030-50SC 4030-502016-08-18
04042409237027NASC 4030-55SC 4030-552016-08-18
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409002939NAIP 8403-002018-02-28
04042409036170NAIP 2505-002018-02-28
04042409207273NAIP 8405-002018-02-28
04042409228995NAIP 8405-502018-02-28

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Primary DI, Brand, Company table
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03700569604318NANEWCLIP TECHNICSHWC2024-11-15
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03700569633936NANEWCLIP TECHNICSHWC2024-11-15
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03700569633974NANEWCLIP TECHNICSHWC2024-11-15
03700569633998NANEWCLIP TECHNICSHWC2024-11-15
03700569634018NANEWCLIP TECHNICSHWC2024-11-15
03700569634032NANEWCLIP TECHNICSHWC2024-11-15
03700569634056NANEWCLIP TECHNICSHWC2024-11-15
09353903015376NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
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