FDA.reportPublic FDA data

AC DEVICE

Primary DI
05060433600319
Brand
AC DEVICE
Company
Lockdown Medical Ltd
Model
LDI627/S
Catalog number
LDIN627/S
Device description
Lockdown AO Drill 2.5mm diameter (Sterile)
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

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
05060433600319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433600319050604336003195060433600319

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, sterileA sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.5Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310650ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310660ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310670ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310680ORTHOMEDORTHO-MED, INC.HTW2026-07-22
00190776403270MillenniumAvalign Technologies, Inc.HTW2026-07-21
08059386748688Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-07-21
B504OM19S17050BrasselerProvisionHTW2026-07-20
B504OM3162880SynthesProvisionHTW2026-07-20
B504OM4058830BiometProvisionHTW2026-07-20
B504OM4058890BiometProvisionHTW2026-07-20
B504OM542022S0StrykerProvisionHTW2026-07-20
B504OM7024470StrykerProvisionHTW2026-07-20
B504OMA37330MedartisProvisionHTW2026-07-20
B504OMAR1214L0ArthrexProvisionHTW2026-07-20
B504OMAR1217L0ArthrexProvisionHTW2026-07-20
B504OMCSS07247SQ0WrightProvisionHTW2026-07-20
B504OMKM166310260BrasselerProvisionHTW2026-07-20
B504OMKM166310680BrasselerProvisionHTW2026-07-20
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17