FDA.reportPublic FDA data

HALLU-LOCK

Primary DI
10381780064473
Brand
HALLU-LOCK
Company
NEWDEAL
Model
HALULCKIMP
Catalog number
HALULCKIMP
Device description
The Hallu-Lock plate system is a low profile titanium plate dedicated to the first metatarsophalangeal arthrodesis. This system includes Hallu-Lock C plates, Hallu-Lock S plates, screws, and instruments. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022599000
K083154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022599000NEWDEAL K WIRENew Deal, S.A.2002-10-30HTY
K083154000NEWDEAL HALLU LOCK PLATE SYSTEMNewdeal Sas2009-07-10HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780064473PrimaryGS10
M248HALULCKIMP1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178006447310381780064473

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Kit
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
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10381780042273ADVANSYS®169102ND2017-05-26
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10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26
10381780042846SURFIX®SET101ND2017-05-26
10381780052005SURFIX®219765ND2017-05-26
10381780052036SURFIX®MA003ND2017-05-26
10381780052166METIS®119601ND2017-05-26
10381780052999PANTA®519130ND2017-05-31
10381780126539TIBIAXYS®159985ND2017-05-26
10381780044574PANTA XL510004ND510004ND2017-10-09

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