FDA.report

StelKast Generic Knee instruments

Primary DI
10840843112136
Brand
StelKast Generic Knee instruments
Company
Stelkast Incorporated
Model
SC3745-4
Device description
CR Femoral Trial- Left with Extraction Slot and Pins, Size 4
Published
2019-04-18
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840843112136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084084311213610840843112136

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1(724)-941-6368customer_service@stelkast.com

Regulatory Flags

DUNS number
804792265
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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10840843100171Provident Hip SystemSC1217-502015-04-15
10840843100188Provident Hip SystemSC1217-522015-04-15
10840843100195Provident Hip SystemSC1217-542015-04-15
10840843100201Provident Hip SystemSC1217-562015-04-15
10840843100218Provident Hip SystemSC1217-582015-04-15
10840843100225Provident Hip SystemSC1217-602015-04-15
10840843100232Provident Hip SystemSC1217-622015-04-15
10840843100249Provident Hip SystemSC1217-642015-04-15
10840843100256Provident Hip SystemSC1217-662015-04-15
10840843100263Provident Hip SystemSC1217-682015-04-15
10840843100270Provident Hip SystemSC1217-702015-04-15
10840843100287Provident Hip SystemSC1217-722015-04-15
10840843100805Zirconia Ceramic HeadSC1405-28mm +0M2015-10-07
10840843100812Zirconia Ceramic HeadSC1405-28mm +3.5 L2015-10-07
10840843100829Zirconia Ceramic HeadSC1405-28mm -3.5 S2015-10-07
10840843100836Zirconia Ceramic HeadSC1406-28mm +7 XL2015-10-07
10840843100843Proform Hip SystemSC1408-100-462015-02-17
10840843100850Proform Hip SystemSC1408-100-482015-02-17

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