FDA.reportPublic FDA data

Logical Cup Curved Inserter

Primary DI
09348215088590
Brand
Logical Cup Curved Inserter
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
112-172-908
Published
2022-02-11
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215088590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215088590093482150885909348215088590

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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

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