FDA.reportPublic FDA data

DYNAFIX VS OSTEOTOMY SYSTEM

Primary DI
00888480153511
Brand
DYNAFIX VS OSTEOTOMY SYSTEM
Company
Biomet Orthopedics, LLC
Model
13225P
Catalog number
13225P
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
00888480153511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480153511008884801535118884801535110888480153511

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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

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