HALLU LOCK 290645SND

GUDID M248290645SND1

The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and the HALLU Lock C plate) and in different sizes (left/right). They are implanted using Newdeal fixed or variable angle locking system fixation screws and washers. They are both low profile Titanium plates dedicated to the first metatarso-phalangeal arthrodesis. Pre-bending is possible to completely fit the anatomical shape of the joint.

NEWDEAL

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDM248290645SND1
NIH Device Record Key8038499f-08b5-4624-95c6-e3a582547c5e
Commercial Distribution Discontinuation2027-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameHALLU LOCK
Version Model Number290645SND
Catalog Number290645SND
Company DUNS536935331
Company NameNEWDEAL
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 Latextrue
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780044260 [Primary]
HIBCCM248290645SND1 [Secondary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-02-09
Device Publish Date2017-10-09

On-Brand Devices [HALLU LOCK]

M248290660SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290655SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044277The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290645SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044253The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290555SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044239The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290545SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044215The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290445SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044192The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290435SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044178The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290345SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044154The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044147The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044130The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
M248290255SND1The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044116The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044109The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044093The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044086The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044079The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
10381780044062The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and
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