FDA.reportPublic FDA data

Trial Cage 15deg 12L

Primary DI
09348215066642
Brand
Trial Cage 15deg 12L
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
135-15-0055
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
09348215066642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215066642093482150666429348215066642

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215019587Evolve AP Cup - Size 28-40111-17-40282026-06-26
09348215019594Evolve AP Cup - Size 28-42111-17-42282026-06-26
09348215019600Evolve AP Cup - Size 28-44111-17-44282026-06-26
09348215019617Evolve AP Cup - Size 28-46111-17-46282026-06-26
09348215019624Evolve AP Cup - Size 28-48111-17-48282026-06-26
09348215019631Evolve AP Cup - Size 28-50111-17-50282026-06-26
09348215019648Evolve AP Cup - Size 28-52111-17-52282026-06-26
09348215019655Evolve AP Cup - Size 28-54111-17-54282026-06-26
09348215019662Evolve AP Cup - Size 28-56111-17-56282026-06-26
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm121-20-41202026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm121-20-42202026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm121-20-43202026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm121-20-44202026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm121-20-45202026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm121-20-46202026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm121-20-47202026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm121-20-48202026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm121-20-49202026-06-26
09348215148980Evolve AP Vit-E Cup – Neutral - Size 32-46111-17-01462026-06-26
09348215148997Evolve AP Vit-E Cup – Neutral - Size 32-48111-17-01482026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21