bioBLOCK® Subtalar Implant System 040009

GUDID M2480400090

The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.

INTEGRA LIFESCIENCES CORPORATION

Subtalar implant, non-bioabsorbable, sterile
Primary Device IDM2480400090
NIH Device Record Keye2277bf3-342f-432b-99af-8951f16887be
Commercial Distribution StatusIn Commercial Distribution
Brand NamebioBLOCK® Subtalar Implant System
Version Model Number040009
Catalog Number040009
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
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

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.
Storage Environment TemperatureBetween 0 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored cool. Do not freeze. Avoid contact with any objects that may damage the surface finish.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780066569 [Primary]
HIBCCM2480400090 [Secondary]

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 Date2021-02-26
Device Publish Date2017-10-09

On-Brand Devices [bioBLOCK® Subtalar Implant System]

M2480400120The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
M2480400110The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
M2480400100The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
M2480400090The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe
M2480400080The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted betwe

Trademark Results [bioBLOCK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOBLOCK
BIOBLOCK
98144498 not registered Live/Pending
Darlene E. McCord
2023-08-22
BIOBLOCK
BIOBLOCK
98092480 not registered Live/Pending
BioSem Inc
2023-07-19
BIOBLOCK
BIOBLOCK
87941544 not registered Dead/Abandoned
Clearwater Engineered Chemistry LLC
2018-05-30
BIOBLOCK
BIOBLOCK
86258886 not registered Dead/Abandoned
Nikken, Inc.
2014-04-22
BIOBLOCK
BIOBLOCK
79195250 5220461 Live/Registered
BIOTECHNOLOGY INSTITUTE, S.L.
2016-07-11
BIOBLOCK
BIOBLOCK
78841905 3490474 Live/Registered
INTEGRA LIFESCIENCES CORPORATION
2006-03-21
BIOBLOCK
BIOBLOCK
78841905 3490474 Live/Registered
SMITH & NEPHEW ORTHOPAEDICS AG
2006-03-21
BIOBLOCK
BIOBLOCK
78841905 3490474 Live/Registered
SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED
2006-03-21
BIOBLOCK
BIOBLOCK
78488781 3757634 Live/Registered
MAPEI S.P.A.
2004-09-23
BIOBLOCK
BIOBLOCK
78372473 not registered Dead/Abandoned
MAPEI Corporation
2004-02-23
BIOBLOCK
BIOBLOCK
77417027 not registered Dead/Abandoned
Recigno Laboratories Inc.
2008-03-09
BIOBLOCK
BIOBLOCK
76590837 not registered Dead/Abandoned
AWI Licensing Company
2004-05-07

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