FDA.reportPublic FDA data

Aurora Trial Plate 21

Primary DI
09348215067113
Brand
Aurora Trial Plate 21
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
132-16-0112
Published
2020-06-30
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

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163625000NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemSignature Orthopaedics Pty, Ltd.2017-08-11KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215067113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215067113093482150671139348215067113

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215010973Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left10-1521-03022026-05-18
09348215010980Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right10-1522-03222026-05-18
09348215010997Active-V Knee Cementless CR Femoral Component - Size 1 - Left10-1521-03032026-05-18
09348215011000Active-V Knee Cementless CR Femoral Component - Size 1 - Right10-1522-03232026-05-18
09348215011017Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left10-1521-03042026-05-18
09348215011024Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right10-1522-03242026-05-18
09348215011031Active-V Knee Cementless CRFemoral Component - Size 2 - Left10-1521-03052026-05-18
09348215011048Active-V Knee Cementless CR Femoral Component - Size 2 - Right10-1522-03252026-05-18
09348215011055Active-V Knee Cementless CRFemoral Component - Size 3 Narrow - Left10-1521-03062026-05-18
09348215011062Active-V Knee Cementless CR Femoral Component - Size 3 Narrow - Right10-1522-03262026-05-18
09348215011079Active-V Knee Cementless CRFemoral Component - Size 3 - Left10-1521-03072026-05-18
09348215011086Active-V Knee Cementless CR Femoral Component - Size 3 - Right10-1522-03272026-05-18
09348215011093Active-V Knee Cementless CRFemoral Component - Size 4 Narrow - Left10-1521-03082026-05-18
09348215011109Active-V Knee Cementless CR Femoral Component - Size 4 Narrow - Right10-1522-03282026-05-18
09348215011116Active-V Knee Cementless CRFemoral Component - Size 4 - Left10-1521-03092026-05-18
09348215011123Active-V Knee Cementless CR Femoral Component - Size 4 - Right10-1522-03292026-05-18
09348215011130Active-V Knee Cementless CRFemoral Component - Size 5 Narrow - Left10-1521-02102026-05-18
09348215011147Active-V Knee Cementless CR Femoral Component - Size 5 Narrow - Right10-1522-02302026-05-18
09348215014506Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 Narrow10-1513-04002026-05-18
09348215014513Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 110-1513-04012026-05-18

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Primary DI, Brand, Company table
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00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
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