FDA.reportPublic FDA data

APTUS

Primary DI
07630894812347
Brand
APTUS
Company
Medartis AG
Model
A-4856.83
Catalog number
A-4856.83
Device description
2.8 TriLock OlecPl Dorsal Medium 11H, L
Published
2025-07-18
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
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240613000APTUS Elbow Dorsal Olecranon PlatesMedartis AG2024-06-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894812347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894812347076308948123477630894812347

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620971Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620575Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26