FDA.reportPublic FDA data

OSSEOTI RECONSTRUCTIVE SYSTEM

Primary DI
00887868106460
Brand
OSSEOTI RECONSTRUCTIVE SYSTEM
Company
Biomet Orthopedics, LLC
Model
110003778
Catalog number
110003778
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
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
00887868106460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868106460008878681064608878681064600887868106460

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809986483911CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483928CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
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08809986484123CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
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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