FDA.reportPublic FDA data

4.0 x 125mm Drill Bit Cann AO

Primary DI
00810074305013
Brand
4.0 x 125mm Drill Bit Cann AO
Company
Osteocentric Technologies, Inc.
Model
320-80023
Catalog number
320-80023
Device description
4.0 x 125mm Drill Bit Cann AO
Published
2024-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170021000SMV Scientific Cannulated ScrewsSmv Scientific2017-05-22HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810074305013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074305013008100743050138100743050130810074305013

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length125Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

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