FDA.reportPublic FDA data

DYNAFIX VS OSTEOTOMY SYSTEM

Primary DI
00880304486089
Brand
DYNAFIX VS OSTEOTOMY SYSTEM
Company
Biomet Orthopedics, LLC
Model
11125P
Catalog number
11125P
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
NDFPLATE, FIXATION, BONE, NON-SPINAL, METALLIC
NDHNAIL, FIXATION, BONE, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDFPlate, Fixation, Bone, Non-Spinal, MetallicOrthopedic2
NDHNail, Fixation, Bone, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010551000EBI DYNAFIX VS OSTEOTOMY SYSTEMEbi, L.P.2001-05-17NDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304486089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304486089008803044860898803044860890880304486089

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

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
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
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124513730PolyLock Small BoneFUSION ORTHOPEDICS, LLCNDF2024-08-01
00840124507548PolyLock SmallBoneFUSION ORTHOPEDICS, LLCNDF2023-06-09
B267101010Flow-Nail™ Flow-FXNDH2020-12-18
B267101100Flow-Nail™ Flow-FXNDH2020-12-18
B267101110Flow-Nail™ Flow-FXNDH2020-12-18
B267101120Flow-Screw™Flow-FXNDH2020-12-18
B267101270Flow-Nail™ Flow-FXNDH2020-12-18
B267101410Flow-Nail™ Flow-FXNDH2020-12-18
B267101540Flow-Nail™ Flow-FXNDH2020-12-18
00889024054066NAZimmer, Inc.NDF2017-10-02
00889024053830NAZimmer, Inc.NDF2017-10-02
00889024053847NAZimmer, Inc.NDF2017-10-02
00889024053854NAZimmer, Inc.NDF2017-10-02
00889024053946NAZimmer, Inc.NDF2017-10-02
00889024053953NAZimmer, Inc.NDF2017-10-02
00889024053960NAZimmer, Inc.NDF2017-10-02
00889024053977NAZimmer, Inc.NDF2017-10-02
00889024053984NAZimmer, Inc.NDF2017-10-02
00889024053991NAZimmer, Inc.NDF2017-10-02
00889024054004NAZimmer, Inc.NDF2017-10-02
00889024054011NAZimmer, Inc.NDF2017-10-02
00889024054028NAZimmer, Inc.NDF2017-10-02
00889024054042NAZimmer, Inc.NDF2017-10-02
00889024054059NAZimmer, Inc.NDF2017-10-02
00889024054073NAZimmer, Inc.NDF2017-10-02
00889024054097NAZimmer, Inc.NDF2017-10-02
00889024054103NAZimmer, Inc.NDF2017-10-02
00887868089916DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868089916DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090011DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24