FDA.reportPublic FDA data

SPIROFIT PINNACLE

Primary DI
10603295079859
Brand
SPIROFIT PINNACLE
Company
DEPUY (IRELAND)
Model
2000-50-066
Catalog number
200050066
Device description
SPIROFIT PINNACLE SCREWING PLATE DIAMETER 66
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXOPUSHER, SOCKET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295079859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329507985910603295079859

GMDN Terms#

Term, Definition table
TermDefinition
Hip prosthesis socket pusherA hand-held manual surgical instrument with a grip designed to hold an acetabular cup or shell at the distal end. It is rod-like in shape and used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541394ATTUNE1518-20-1161518201162021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701313009526KHEIRONS.M.A.I.OHXO2026-07-06
03701313009519KHEIRONS.M.A.I.OHXO2026-07-05
00850011453537Remedy Poly+Plus Acetabular CupOSTEOREMEDIES, LLCHXO2026-06-01
108500705004914.0mm Dual Obturator CURVAFIX, INC.HXO2025-10-22
04719878788106“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2025-10-15
04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500510MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500527MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500909MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501050MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501357MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501364MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501388MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501395MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501425MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14