FDA.reportPublic FDA data

Screw Caddy

Primary DI
09348215066949
Brand
Screw Caddy
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
132-16-0039
Published
2020-07-01
Public version status
Update
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
09348215066949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215066949093482150669499348215066949

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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
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

Other Devices Sharing Product Codes#

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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