FDA.report

Endo-Model Knee System - Instruments

Primary DI
04026575167258
Brand
Endo-Model Knee System - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
15-0036/52
Device description
Orthopaedic implant inserter/extractor, reusable - Endo Model Knee System
Published
2023-01-04
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
HXOPUSHER, SOCKET

Product Code Classifications

CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575167258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026575167258040265751672584026575167258

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315675488
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02
04026575081059MP Reconstruction System Instruments134-051/002026-02-02
04026575083183Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-01/012026-02-02
04026575083206Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-05/052026-02-02
04026575083664Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-02/022026-02-02
04026575083718Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-03/032026-02-02
04026575090242Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-06/062026-02-02
04026575092239General Instrument151-07/072026-02-02
04026575092291General Instrument151-08/082026-02-02
04026575129904MP Reconstruction System Instruments134-071/002026-02-02
04026575129928MP Reconstruction System Instruments134-081/002026-02-02
04026575131426MP Reconstruction System Instruments134-091/002026-02-02
04026575181926MP Monoblock Hip Stem Instruments136-021/002026-02-02
04026575181988MP Monoblock Hip Stem Instruments136-031/002026-02-02
04026575182022MP Monoblock Hip Stem Instruments136-011/002026-02-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMInnosys Co., Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500510MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500527MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500909MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501050MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501357MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501364MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501388MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501395MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501425MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763501333MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763505188MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
00887868567490Closed Knot PusherBiomet Orthopedics, LLCHXO2023-05-29
06970399633780RapidLinkHangzhou Rejoin Mastin Medical Device Co., Ltd.HXO2023-05-22
08800037575500ANAX™ 5.5 SPINAL SYSTEMU&I CORPORATIONHXO2023-04-10
00885556861608Titan Modular Shoulder System 2.5Smith & Nephew, Inc.HXO2023-02-02
B5620906850Sterile Spine Pedicle Screw SystemWISHBONE MEDICAL, INC.HXO2023-02-02
04026575398171LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHXO2023-01-11