FDA.reportPublic FDA data

PINNACLE

Primary DI
10603295009900
Brand
PINNACLE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1217-25-500
Catalog number
121725500
Device description
PINNACLE CANCELLOUS BONE SCREW 6.5mm x 25mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983014000SUMMIT ACETABULAR SYSTEMJohnson & Johnson Professionals, Inc.1998-10-27LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295009900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500990010603295009900

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., surgical steel).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
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04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
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00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
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00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
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00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
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00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
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00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26