FDA.reportPublic FDA data

APTUS

Primary DI
07630037879893
Brand
APTUS
Company
Medartis AG
Model
A-5250.10
Catalog number
A-5250.10
Device description
1.5 TriLock Screw 10mm, HD4, 5/Pkg
Published
2023-02-24
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
K102537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102537000APTUS 1.5 TRILOCKMedartis AG2010-12-10HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630008430443PreviousGS10
07630037879893PrimaryGS10
07630037800453Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630008430443076300084304437630008430443
07630037879893076300378798937630037879893
07630037800453076300378004537630037800453

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."

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
5
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
07630008400613APTUSA-2047A-20472026-07-16
07630008405793APTUSA-6095.05A-6095.052026-07-16
07630008405809APTUSA-6095.06A-6095.062026-07-16
07630008405878APTUSA-6095.13A-6095.132026-07-16
07630008405892APTUSA-6095.15A-6095.152026-07-16
07630008406226APTUSA-6095.61A-6095.612026-07-16
07630008406233APTUSA-6095.62A-6095.622026-07-16
07630008406240APTUSA-6095.63A-6095.632026-07-16
07630008406257APTUSA-6095.64A-6095.642026-07-16
07630008406264APTUSA-6095.65A-6095.652026-07-16
07630008406271APTUSA-6095.66A-6095.662026-07-16
07630008406288APTUSA-6095.67A-6095.672026-07-16
07630008406295APTUSA-6095.70A-6095.702026-07-16
07630008406301APTUSA-6095.71A-6095.712026-07-16
07630008406318APTUSA-6095.72A-6095.722026-07-16
07630008406325APTUSA-6095.73A-6095.732026-07-16
07630008406332APTUSA-6095.74A-6095.742026-07-16
07630008428327APTUSA-6095.68A-6095.682026-07-16
07630008428334APTUSA-6095.69A-6095.692026-07-16
07630008439866APTUSA-3837A-38372026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903016311NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
09353903016328NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
03700569604233NANEWCLIP TECHNICSHWC2024-11-15
03700569604257NANEWCLIP TECHNICSHWC2024-11-15
03700569604271NANEWCLIP TECHNICSHWC2024-11-15
03700569604295NANEWCLIP TECHNICSHWC2024-11-15
03700569604318NANEWCLIP TECHNICSHWC2024-11-15
03700569604332NANEWCLIP TECHNICSHWC2024-11-15
03700569604356NANEWCLIP TECHNICSHWC2024-11-15
03700569604370NANEWCLIP TECHNICSHWC2024-11-15
03700569633936NANEWCLIP TECHNICSHWC2024-11-15
03700569633950NANEWCLIP TECHNICSHWC2024-11-15
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
09353903015383NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015390NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015406NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015413NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015420NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015437NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015444NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015451NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015468NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015475NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015482NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015499NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16