FDA.report

Consensus Hip System

Primary DI
00840286853972
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
1800-1-1102
Catalog number
1800-1-1102
Device description
Calcar Cutter, Medium
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
HTPFile

Product Code Classifications

CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840286853972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286853972008402868539728402868539720840286853972

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840286855648CS2 Acetabular System1905-1-00421905-1-00422025-09-22
00840286856676CS2 Acetabular System1904-2-28581904-2-28582025-09-22
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
00840286853132Consensus Knee System2800-0-20142800-0-20142025-06-04
00840286841016Bipolar Hip System55050-0055050-002025-05-22
00840286841023Bipolar Hip System1914-2-00001914-2-00002025-05-22
00840286841030Bipolar Hip System1814-0-42441814-0-42442025-05-22
00840286841047Bipolar Hip System1814-0-45471814-0-45472025-05-22
00840286841054Bipolar Hip System1814-0-48501814-0-48502025-05-22
00840286841061Bipolar Hip System1814-0-51531814-0-51532025-05-22
00840286841078Bipolar Hip System1814-0-54561814-0-54562025-05-22
00840286841085Bipolar Hip System1814-0-57591814-0-57592025-05-22
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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