OTIS-C PLUS EVO9066075

GUDID 03760154001397

316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

S.B.M

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID03760154001397
NIH Device Record Key3786af4e-d111-44a6-a5f7-f3234caff70b
Commercial Distribution Discontinuation2020-01-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOTIS-C PLUS
Version Model NumberScrew for OTIS-C PLUS plate fixation
Catalog NumberEVO9066075
Company DUNS772462123
Company NameS.B.M
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

Phone781-369-1782
Emailgboue@s-b-m.us
Phone781-369-1782
Emailgboue@s-b-m.us

Device Dimensions

Outer Diameter6.5 Millimeter
Length75 Millimeter
Outer Diameter6.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154001397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-10
Device Publish Date2015-10-16

On-Brand Devices [OTIS-C PLUS]

03760154004794NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
03760154004770NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004756NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
03760154004749NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate.
03760154004732NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004718NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004701NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004695NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004497NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004480NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004459NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004190NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004169NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154004152NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gu
03760154004145NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154007924316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154005142316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Pl
03760154005135316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Pl
03760154001397316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001281316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001274316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001267316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001250316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001243316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001236316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001229316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001212316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001205316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001199316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001182316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001175316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.
03760154001113Screw for temporary fixation of OTIS-C PLUS osteosynthesis plate for HTO.

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