FDA.reportPublic FDA data

OSSEOTI RECONSTRUCTIVE WEDGE

Primary DI
00880304562820
Brand
OSSEOTI RECONSTRUCTIVE WEDGE
Company
Biomet Orthopedics, LLC
Model
597009
Catalog number
597009
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122770000BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831Biomet Manufacturing Corp2013-03-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304562820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304562820008803045628208803045628200880304562820

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986483843CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483850CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483867CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483874CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483881CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483898CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483904CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483911CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483928CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484048CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484123CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484147CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484154CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484161CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484178CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484185CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484192CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484208CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484215CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484222CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484239CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484345CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484352CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484369CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484376CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484383CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484390CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484406CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484413CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484420CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28