FDA.report

Endo-Model Knee System - Instruments

Primary DI
04026575295371
Brand
Endo-Model Knee System - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
317-585/65
Device description
Orthopaedic implant inserter/extractor, reusable - General Instrument
Published
2023-01-11
Public version status
Update
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
HXQCRIMPER, PIN

Product Code Classifications

CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575295371PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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

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