FDA.reportPublic FDA data

ROSA® Shoulder

Primary DI
00887868558290
Brand
ROSA® Shoulder
Company
Orthosoft Inc
Model
20-8087-503-00
Catalog number
20808750300
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868558290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868558290008878685582908878685582900887868558290

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, reusableA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)336-7846zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868579219OptiVu™ Mixed RealityOVMR-SW-2-0201OVMR-SW-2-02012023-09-07
00887868579226OptiVu™ Mixed RealityOVMR-SW-2-0202OVMR-SW-2-02022023-09-07
00887868554483OptiVu™ Mixed RealityOVMR-SW-2-0005OVMR-SW-2-00052023-03-31
00887868554490OptiVu™ Mixed RealityOVMR-SW-2-0006OVMR-SW-2-00062023-03-31
00887868519017iASSIST® Knee System20-8011-501-0020-8011-501-002022-11-15
00887868519130iASSIST® Knee System20-8000-070-0220-8000-070-022022-11-14
00887868519154iASSIST® Knee System20-8011-063-0020-8011-063-002022-11-14
00887868519161iASSIST® Knee System20-8011-065-0020-8011-065-002022-11-14
00887868540509iASSIST® Knee System20-8011-501-002022-10-17
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00887868557590X-PSI Knee803.308803.3082022-08-11
00887868557606PSI Knee803.302803.3022022-08-11
00887868522987Signature ONE20-8090-008-012022-07-20
00887868522994Signature ONE20-8090-008-022022-07-20
00887868523106ONE Planner HipCG200CG2002021-07-28
00889024563643iASSIST®20-8000-000-2020-8000-000-202021-02-18

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Primary DI, Brand, Company table
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