FDA.reportPublic FDA data

Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left

Primary DI
00889024563391
Brand
Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left
Company
Orthosoft Inc
Model
20-8090-004-01
Catalog number
20-8090-004-01
Published
2019-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QHEShoulder Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190595000Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-06-05KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024563391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024563391008890245633918890245633910889024563391

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
574-371-3710personalizedsolutions@zimmerbiomet.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21
00889024478961Camera Kit20-8000-070-9920-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer Kit20-8000-070-7720-8000-070-772016-12-21
00889024485518AC power cord North America20-8000-070-7120-8000-070-712016-12-21
00889024488502Sesamoid Plasty V2 HDMI Cable 30'20-8000-071-242017-04-10
00889024492752NA20-8000-070-212017-09-12
00889024492769NA20-8000-070-462017-09-12
00889024511026ROSA® Recon Platform20-8020-100-0120-8020-100-012019-03-06
00889024511170ROSA® Recon20-8020-110-0120-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNIT20-8020-120-0120-8020-120-012019-03-06

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Primary DI, Brand, Company table
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00810022403068CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403099CORE Shoulder SystemLink Bio CorpQHE2025-06-04
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07630542730153MyShoulder PlannerMedacta International SAQHE2025-02-06
05420060366116Match Point SystemMaterialise NVQHE2024-12-09
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00888867264953Arthrex®ARTHREX, INC.QHE2024-09-03
05420060367120AtlasPlanMaterialise NVQHE2024-07-19
03700434023695Shoulder iDTORNIERQHE2024-05-23
03700434023701Shoulder iDTORNIERQHE2024-05-23
03700434023718Shoulder iDTORNIERQHE2024-05-23
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03700434023732Shoulder iDTORNIERQHE2024-05-23