FDA.reportPublic FDA data

ROSA Hip Impaction Instrument Case

Primary DI
00889024618947
Brand
ROSA Hip Impaction Instrument Case
Company
Zimmer, Inc.
Model
20-8060-306-00
Catalog number
20-8060-306-00
Published
2021-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210998000ROSA Hip SystemOrthosoft D/B/A Zimmer Cas2021-08-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024618947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024618947008890246189478890246189470889024618947

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707467Z1® Hip System6117776126117776122026-07-29
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10

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ESAM1380200003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1380210003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1387030003041STOMA®Storz am Mark GmbHFSM2026-07-30
03700569678968Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-28
10889950157623Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-28
00190376768748Segmental Plating SystemALPHATEC SPINE, INC.FSM2026-07-27
00810017915118Saber-C Instrument CaseELEVATION SPINE, INC.FSM2026-07-27
03700569674304Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674311Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
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03700569674397Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674403Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
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03700569680176Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24