APTUS

Primary DI
07630037895732
Brand
APTUS
Company
Medartis AG
Model
A-4857.02
Catalog number
A-4857.02
Device description
2.8 TriLock Radius Shaft Pl 14 Hole,t3.4
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
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193554000APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG2020-02-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037827474PreviousGS10
07630037895732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037827474076300378274747630037827474
07630037895732076300378957327630037895732

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
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
07901125621176Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-09-18
07901125621183Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-09-18
07901125621190Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-09-18
07901125621206Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-09-18
00885556819845Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819852Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556846599Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-27
00885556910245UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-27
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819807UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819814UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819821UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819838UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819623Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819647SURFIXTotal Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819661Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819685Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819708Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00889795120199Paragon 28 Bone Wedge SystemParagon 28, Inc.HRS2023-06-26
00885556838303Total Foot System 2Smith & Nephew, Inc.HRS2023-04-25
00885556838327Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
00889795120632Paragon 28 Bone Wedge SystemParagon 28, Inc.HRS2023-04-04
00885556838099Total Foot System 2Smith & Nephew, Inc.HRS2022-12-22