FDA.reportPublic FDA data

APTUS

Primary DI
07630037891901
Brand
APTUS
Company
Medartis AG
Model
A-4950.12S
Catalog number
A-4950.12S
Device description
3.5 TriLock Calc. Step Pl 5H, Step 12mm
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037891901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037891901076300378919017630037891901

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

Regulatory Flags#

DUNS number
480054895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894829079APTUSA-2065A-20652026-01-09
07630894829062APTUSA-2056A-20562025-12-15
07630037863670APTUSA-4750.70/1SA-4750.70/1S2025-07-31
07630037865889APTUSA-3837SA-3837S2025-07-31
07630037883791APTUSA-5800.65/1SA-5800.65/1S2025-07-31
07630037883821APTUSA-5800.70/1SA-5800.70/1S2025-07-31
07630037883852APTUSA-5800.75/1SA-5800.75/1S2025-07-31
07630037883975APTUSA-5830.40/1SA-5830.40/1S2025-07-31
07630037883999APTUSA-5830.45/1SA-5830.45/1S2025-07-31
07630037884019APTUSA-5830.50/1SA-5830.50/1S2025-07-31
07630037884033APTUSA-5830.55/1SA-5830.55/1S2025-07-31
07630037884057APTUSA-5830.60/1SA-5830.60/1S2025-07-31
07630037884071APTUSA-5830.65/1SA-5830.65/1S2025-07-31
07630037884095APTUSA-5830.70/1SA-5830.70/1S2025-07-31
07630037884101APTUSA-5830.75/1SA-5830.75/1S2025-07-31
07630037884767APTUSA-5850.65/1SA-5850.65/1S2025-07-31
07630037884798APTUSA-5850.70/1SA-5850.70/1S2025-07-31
07630037884828APTUSA-5850.75/1SA-5850.75/1S2025-07-31
07630037897125APTUSA-4350.14TPA-4350.14TP2025-07-31
07630894811784APTUSA-4340.32TPA-4340.32TP2025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23