Additive Orthopaedics MTP Cup and Cone Bone Segment

GUDID 00850005508335

Additive Orthopaedics MTP Cup and Cone Bone Segment 12mmx18mm

ADDITIVE ORTHOPAEDICS LLC

Metallic osteotomy fusion cage, sterile
Primary Device ID00850005508335
NIH Device Record Keyba27421f-02fd-4e1a-9aa3-65b50a791011
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdditive Orthopaedics MTP Cup and Cone Bone Segment
Version Model NumberAOMTPW-12-18
Company DUNS085503457
Company NameADDITIVE ORTHOPAEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com
Phone732-882-6633
Emailgreg@additiveorthopaedics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005508335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-01
Device Publish Date2019-07-24

On-Brand Devices [Additive Orthopaedics MTP Cup and Cone Bone Segment]

00850005508397Additive Orthopaedics MTP Cup and Cone Bone Segment 14mmx16mm
00850005508380Additive Orthopaedics MTP Cup and Cone Bone Segment 12mmx16mm
00850005508373Additive Orthopaedics MTP Cup and Cone Bone Segment 10mmx16mm
00850005508366Additive Orthopaedics MTP Cup and Cone Bone Segment 8mmx16mm
00850005508359Additive Orthopaedics MTP Cup and Cone Bone Segment 6mmx16mm
00850005508342Additive Orthopaedics MTP Cup and Cone Bone Segment 14mmx18mm
00850005508335Additive Orthopaedics MTP Cup and Cone Bone Segment 12mmx18mm
00850005508328Additive Orthopaedics MTP Cup and Cone Bone Segment 10mmx18mm
00850005508311Additive Orthopaedics MTP Cup and Cone Bone Segment 8mmx18mm
00850005508304Additive Orthopaedics MTP Cup and Cone Bone Segment 6mmx18mm

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