FDA.reportPublic FDA data

NA

Primary DI
07613252133537
Brand
NA
Company
Howmedica Osteonics Corp.
Model
5444-0-100
Catalog number
5444-0-100
Device description
CMF CUSTOMIZED IMPLANT KIT SMALL
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKYMATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103010000STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics2010-10-26KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252133537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252133537076132521335377613252133537

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324542HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-05-14
00810188323965HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188323972HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188322555HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810188322562HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810128537384HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2024-09-09
00810128531702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-08-08
00810128531795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-07-25
00810128530149HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810128530156HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810077249741HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-02-16
00810077249284HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-18
00810077248959HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-04
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-08
00810077245828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-06-21
00810077245675HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-05-20
00810077244937HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-04-20
00810077243312HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-14
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-05
00810023928409HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2021-01-22
00810023927631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-11-09
00810023925477HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-06-23
00810023924920HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-04-30
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15
00810042038486HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-03-21
00810042036857HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2018-12-03