FDA.reportPublic FDA data

AIM™DYNAMIC TIBIAL NAIL

Primary DI
00887868035302
Brand
AIM™DYNAMIC TIBIAL NAIL
Company
Biomet Orthopedics, LLC
Model
8105-12-420
Catalog number
810512420
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972183000DEPUY ACE A.I.M. TITANIUM TIBIAL NAILAce Medical Co.1997-08-26HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868035302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868035302008878680353028878680353020887868035302

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

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

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024709188DISTAL GRADUATED DRILL SHORT2112-01-4062112014062026-07-24
00889024709195DRILL MEASURING SLEEVE2112-01-4102112014102026-07-24
00880304533424DVR® CrosslockWIDE PLATE RIGHT (HEAD WIDTH x OVERALL LENGTH)1318130501318130502015-10-24
00889024707726SolidLok®2810-01-0212810010212026-06-10
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015376838Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376845Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376852Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376883Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376968Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376975Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376999Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377002Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377019Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377026Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377033Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377040Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377057Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377064Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377071Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377088Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377095Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377101Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377118Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377125Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23