FDA.reportPublic FDA data

Avalign

Primary DI
00190776032548
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM85-2619
Device description
Cloward Style Dowel
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWLSET, HOLLOW MILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWLSet, Hollow MillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776032548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776032548001907760325481907760325480190776032548

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776437329Millennium1-803EB2026-11-02
00190776437336Millennium1-80111EB2026-11-02
00190776437343Millennium1-750EB2026-11-02
00190776437350Millennium1-911172026-11-02
00190776437367Millennium1-BIO11042C2026-11-02
00190776437374Millennium1-SS937182026-11-02
00190776437381Millennium1-620030012026-11-02
00190776437398Millennium1-3104952026-11-02
00190776437404Millennium1-1852312026-11-02
00190776437411Millennium1-1851962026-11-02
00190776437428Millennium72-2358702042026-11-02
00190776437435Millennium72-2358702012026-11-02
00190776437442Millennium1-1103332026-11-02
00190776437459Millennium1-500135L2026-11-02
00190776437466Millennium1-2302142026-11-02
00190776437237Millennium1-121195EB2026-10-30
00190776437244Millennium1-018EB2026-10-30
00190776437251Millennium1-010EB2026-10-30
00190776437268Millennium1-7772EB2026-10-30
00190776437275Millennium1-7082EB2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437019739966WasherCap™ Surgical Instrument SetABANZA TECNOMED SL.HWL2023-06-01
06973877662722RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662739RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662746RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662753RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662760RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662777RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662814RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662852RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662869RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877663019RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667932RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667956RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667963RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667970RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667987RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
04047844111673COSYSIGNUS Medizintechnik GmbHHWL2023-03-15
07613327417289INSTRUMENTHowmedica Osteonics Corp.HWL2018-06-01
00190776032555AvalignAvalign Technologies, Inc.HWL2017-05-01
00889024023215NAZimmer, Inc.HWL2016-07-26
00889024023222NAZimmer, Inc.HWL2016-07-26
00889024023239NAZimmer, Inc.HWL2016-07-26
00889024023246NAZimmer, Inc.HWL2016-07-26
00889024039742ZMS®Zimmer, Inc.HWL2016-07-26