PINNACLE 121798446

GUDID 10603295534372

PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF072320.008) FOR CEMENTLESS USE ONLY 56MM RIGHT

DEPUY ORTHOPAEDICS, INC.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID10603295534372
NIH Device Record Keye7290d50-2bf9-409b-a3fb-c3f4a8376165
Commercial Distribution StatusIn Commercial Distribution
Brand NamePINNACLE
Version Model Number1217-98-446
Catalog Number121798446
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]
GS110603295534372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [PINNACLE]

10603295511533PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF022119.004) FOR CEMENTLESS USE ONLY 56MM LEFT
10603295510949PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF121218.005) FOR CEMENTLESS USE ONLY 66MM RIGHT
10603295511571PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF111418.004) FOR CEMENTLESS USE ONLY 56MM LEFT
10603295511564PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF030719.005) FOR CEMENTLESS USE ONLY 62MM LEFT
10603295511519PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF011019.005) FOR CEMENTLESS USE ONLY 52MM RIGHT
10603295511557PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF021419.003) FOR CEMENTLESS USE ONLY 62MM RIGHT
10603295102359PINNACLE GRIPPER 66mm
10603295102342PINNACLE GRIPPER 64mm
10603295102335PINNACLE GRIPPER 62mm
10603295102328PINNACLE GRIPPER 60mm
10603295102311PINNACLE GRIPPER 58mm
10603295102304PINNACLE GRIPPER 56mm
10603295102298PINNACLE GRIPPER 54mm
10603295102281PINNACLE GRIPPER 52mm
10603295102274PINNACLE GRIPPER 50mm
10603295102267PINNACLE GRIPPER 48mm
10603295102250PINNACLE GRIPPER 46mm
10603295102243PINNACLE GRIPPER 44mm
10603295102236PINNACLE AB GRIPPER TIP 32mm
10603295102229PINNACLE TIP 44mm
10603295102212PINNACLE TIP 40mm
10603295102199PINNACLE TIP 36mm
10603295102182PINNACLE TIP 28mm
10603295098928PINNACLE POLY EXTRACTOR
10603295097358PINNACLE ALTER BEARING EXTRACTOR BODY 66mm
10603295097341PINNACLE ALTER BEARING EXTRACTOR BODY 64mm
10603295097334PINNACLE ALTER BEARING EXTRACTOR BODY 62mm
10603295097327PINNACLE ALTER BEARING EXTRACTOR BODY 60mm
10603295097310PINNACLE ALTER BEARING EXTRACTOR BODY 58mm
10603295097303PINNACLE ALTER BEARING EXTRACTOR BODY 56mm
10603295097297PINNACLE ALTER BEARING EXTRACTOR BODY 54mm
10603295097280PINNACLE ALTER BEARING EXTRACTOR BODY 52mm
10603295097273PINNACLE ALTER BEARING EXTRACTOR BODY 50mm
10603295097266PINNACLE ALTER BEARING EXTRACTOR BODY 48mm
10603295097259PINNACLE ALTER BEARING EXTRACTOR BODY 46mm
10603295097242PINNACLE ALTER BEARING EXTRACTOR BODY 44mm
10603295097235PINNACLE ALTERNATE BEARING SUCTION CUP INSERTER
10603295511052PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF113018.013) FOR CEMENTLESS USE ONLY 56MM RIGHT
10603295511717PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF032119.009) FOR CEMENTLESS USE ONLY 56MM LEFT
10603295511670PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF032019.008) FOR CEMENTLESS USE ONLY 54MM RIGHT
10603295510956PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF112618.012) FOR CEMENTLESS USE ONLY 48MM RIGHT
10603295511649PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF041619.006) FOR CEMENTLESS USE ONLY 66MM LEFT
10603295511588PINNACLE TRI-FLANGE ACETABULAR CUP W/O HA (TF030419.002) FOR CEMENTLESS USE ONLY 56MM RIGHT
10603295511083PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF121118.003) FOR CEMENTLESS USE ONLY 56MM RIGHT
10603295514091PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF060419.001) FOR CEMENTLESS USE ONLY 54MM RIGHT
10603295513377PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF061419.006) FOR CEMENTLESS USE ONLY 58MM LEFT
10603295513353PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF071719.006) FOR CEMENTLESS USE ONLY 52MM LEFT
10603295513391PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF072319.007) FOR CEMENTLESS USE ONLY 48MM LEFT
10603295513384PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF060519.002) FOR CEMENTLESS USE ONLY 66MM LEFT
10603295511700PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF100418.001) FOR CEMENTLESS USE ONLY 50MM RIGHT

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