FDA.report

Consensus Knee System

Primary DI
00840286854412
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2810-0-1025
Catalog number
2810-0-1025
Device description
CKS, Insert, Modular Femoral Alignement Guide, 5°
Published
2025-05-22
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
00840286854412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286854412008402868544128402868544120840286854412

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags

DUNS number
085976260
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
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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00840286860024Consensus Knee System2800-0-20232800-0-20232025-07-07
00840286860031Consensus Knee System2800-0-20242800-0-20242025-07-07
00840286860079Consensus Knee System2800-0-20252800-0-20252025-07-07
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00840286841092Bipolar Hip System1814-0-60621814-0-60622025-05-22
00840286841108Bipolar Hip System1914-0-00421914-0-00422025-05-22
00840286841115Bipolar Hip System1914-0-00431914-0-00432025-05-22
00840286841122Bipolar Hip System1914-0-00441914-0-00442025-05-22
00840286841139Bipolar Hip System1914-0-00451914-0-00452025-05-22
00840286841146Bipolar Hip System1914-0-00461914-0-00462025-05-22

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