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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017584A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00810030811671InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
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08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05