FDA.report

APTUS

Primary DI
07630894801686
Brand
APTUS
Company
Medartis AG
Model
A-4750.94TP
Catalog number
A-4750.94TP
Device description
Template for A-4750.94
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K223853000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223853000Medartis APTUS® Ulna PlatesMedartis AG2023-03-30HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630894801686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630894801686076308948016867630894801686

GMDN Terms

TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
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
00888867535152Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535176Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535190Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535213Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535237Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535251Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535275Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535299Arthrex®ARTHREX, INC.HRS2026-02-23