FDA.reportPublic FDA data

Shoulder Bone Model Only 3.2mm Pin

Primary DI
00889024563414
Brand
Shoulder Bone Model Only 3.2mm Pin
Company
Orthosoft Inc
Model
20-8090-005-00
Catalog number
20-8090-005-00
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
00889024563414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024563414008890245634148890245634140889024563414

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
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
00889024699762ROSA® Shoulder20-8087-142-0020-8087-142-002026-06-26
00889024699779ROSA® Shoulder20-8087-141-0020-8087-141-002026-06-26
00889024699786ROSA® Shoulder20-8087-150-0120-8087-150-012026-06-26
00889024699793ROSA® Shoulder20-8087-151-0020-8087-151-002026-06-26
00889024699809ROSA® Shoulder20-8087-150-0220-8087-150-022026-06-26
00889024699816ROSA® Shoulder20-8087-150-0320-8087-150-032026-06-26
00889024699823ROSA® Shoulder20-8087-140-0020-8087-140-002026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
05404028001288SurgiCase PlannerMaterialise NVQHE2026-07-16
00889024707047Signature ONE Software PackageOrthosoft IncQHE2026-07-10
05404028001110SurgiCase Planner Materialise NVQHE2025-12-17
05404028001028SurgiCase Planner Materialise NVQHE2025-08-28
03700434023831BlueprintTORNIERQHE2025-06-17
03700434023848BlueprintTORNIERQHE2025-06-17
00810022403051CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403068CORE Shoulder SystemLink Bio CorpQHE2025-06-04
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00810022403136CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403143CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403150CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403167CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403174CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403181CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403198CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403204CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00888867498952Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498969Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498976Arthrex®ARTHREX, INC.QHE2025-05-01
07630542730153MyShoulder PlannerMedacta International SAQHE2025-02-06
05420060366116Match Point SystemMaterialise NVQHE2024-12-09
05420060366123Match Point SystemMaterialise NVQHE2024-12-09