FDA.reportPublic FDA data

DYNAFIX VS OSTEOTOMY SYSTEM

Primary DI
00880304495067
Brand
DYNAFIX VS OSTEOTOMY SYSTEM
Company
Biomet Orthopedics, LLC
Model
12150P
Catalog number
12150P
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
00880304495067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304495067008803044950678803044950670880304495067

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
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

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