FDA.reportPublic FDA data

Bone Plug

Primary DI
07613327036664
Brand
Bone Plug
Company
Howmedica Osteonics Corp.
Model
6215-5-001
Catalog number
6215-5-001
Device description
Canal -Cemented
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZNCEMENT OBTURATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZNCement ObturatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220838000
K951860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220838000Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics2022-05-20LZN
K951860000HOWMEDICE BONE PLUGHowmedica Corp.1995-05-16LZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327036664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327036664076133270366647613327036664

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
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
03760177046542CLEARCUTTEKNIMEDLZN2020-11-25
03760177046573CLEARCUTTEKNIMEDLZN2020-11-25
03760177046603CLEARCUTTEKNIMEDLZN2020-11-25
03760177046634CLEARCUTTEKNIMEDLZN2020-11-25
03760177046665CLEARCUTTEKNIMEDLZN2020-11-25
03760177046696CLEARCUTTEKNIMEDLZN2020-11-25
03760177046535CLEARCUTTEKNIMEDLZN2020-09-24
00889024510326NAZimmer, Inc.LZN2018-09-14
00889024510333NAZimmer, Inc.LZN2018-09-14
00889024510340NAZimmer, Inc.LZN2018-09-14
00889024510357NAZimmer, Inc.LZN2018-09-14
00889024510364NAZimmer, Inc.LZN2018-09-14
00889024510371NAZimmer, Inc.LZN2018-09-14
00888912023443DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023450DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023467DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023474DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023481DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912073806DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00889024376724NAZimmer, Inc.LZN2016-08-31
00889024376748NAZimmer, Inc.LZN2016-08-31
00889024376755NAZimmer, Inc.LZN2016-08-31
00889024380189NAZimmer, Inc.LZN2016-08-31
00889024432918NAZimmer, Inc.LZN2016-07-15
00889024432970NAZimmer, Inc.LZN2016-05-24
00889024432987NAZimmer, Inc.LZN2016-05-24
00889024432994NAZimmer, Inc.LZN2016-05-24
00889024433007NAZimmer, Inc.LZN2016-05-24
00889024433014NAZimmer, Inc.LZN2016-05-24
00889024433021NAZimmer, Inc.LZN2016-05-24