FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528125250
Brand
OsteoMed
Company
OSTEOMED LLC
Model
336-3571-SP-02
Catalog number
336-3571-SP-02
Device description
EXTREMILOCK FOOT 2.7 2H LONG PLATE
Published
2019-11-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528125250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528125250008425281252508425281252500842528125250

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1.8Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986490001CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490018CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490025CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490032CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490049CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490056CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490063CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490087CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490094CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490100CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490117CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490124CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490131CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490148CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490155CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490162CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490179CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490186CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490193CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490209CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490216CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490223CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490230CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490247CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490254CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490261CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490278CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490285CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490292CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490308CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27