FDA.reportPublic FDA data

AC DEVICE

Primary DI
05060433600333
Brand
AC DEVICE
Company
Lockdown Medical Ltd
Model
LDLG
Catalog number
LDLG
Device description
LockDown Acromioclavicular (AC) Length Gauge
Published
2017-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091207000SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICESurgicraft , Ltd.2011-02-15HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060433600333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433600333050604336003335060433600333

GMDN Terms#

Term, Definition table
TermDefinition
Ligament prosthesisA sterile, implantable, non-bioabsorbable device intended to be used as a direct ligament substitute to replace a missing or damaged ligament for restoring natural function. It is made of synthetic polymer materials (e.g., polyester), and some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto the bone; disposable devices associated with implantation may be included. It is commonly used for ligament reconstruction in the knee [e.g., patellofemoral ligament, anterior cruciate ligament (ACL)] or shoulder (e.g., glenohumeral ligament) joints.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211167885
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060433600326AC DEVICELDIN628/SLDIN628/S2017-02-23
05060433600845LSSSRM04953RM049532020-07-24
05060433600920LSSSRM06005RM060052020-07-24
05060433600005AC DEVICELD050LD0502015-10-30
05060433600012AC DEVICELD060LD0602015-10-30
05060433600029AC DEVICELD070LD0702015-10-30
05060433600036AC DEVICELD080LD0802015-10-30
05060433600043AC DEVICELD090LD0902015-10-30
05060433600050AC DEVICELD100LD1002015-10-30
05060433600067AC DEVICELD110LD1102015-10-30
05060433600074AC DEVICELD120LD1202015-10-30
05060433600081AC DEVICELD130LD1302015-10-30
05060433600098AC DEVICELD140LD1402015-10-30
05060433600104AC DEVICELD150LD1502015-10-30
05060433600111AC DEVICELD160LD1602015-10-30
05060433600128AC DEVICELD170LD1702015-10-30
05060433600135AC DEVICELD180LD1802015-10-30
05060433600142AC DEVICELD190LD1902015-10-30
05060433600159AC DEVICELD200LD2002015-10-30
05060433600166AC DEVICELDCW09LDCW092015-10-30

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