FDA.reportPublic FDA data

MODULAR FLEXIBLE REAMER HEAD, Ø14.5mm

Primary DI
00848665000962
Brand
MODULAR FLEXIBLE REAMER HEAD, Ø14.5mm
Company
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Model
0234-145
Published
2016-02-23
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
HSBRod, Fixation, Intramedullary And Accessories
HTWBit, Drill
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012190000AOS MODULAR FEMORAL NAILAdvanced Orthopaedic Solutions, Inc.2001-09-24HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665000962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665000962008486650009628486650009620848665000962

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, flexibleAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(310) 533-9966regaffairs@aosortho.com

Regulatory Flags#

DUNS number
117858154
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848665004021AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mmS1047-0192015-12-02
00848665004052AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 5mmS1047-0592015-12-02
00848665004083AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 10mmS1047-1092015-12-02
00848665004106AOS CAPTURED END CAP WITH POST 1mmS1048-0192015-12-02
00848665004823AOS END CAP, HUMERAL NAIL 2mmS1074-0202015-12-04
00848665004830AOS END CAP, HUMERAL NAIL 5mmS1074-0502015-12-05
00848665005332AOS END CAP, TIBIAL NAIL 5mmS1115-0502015-12-15
00848665005349AOS END CAP, TIBIAL NAIL 10mmS1115-1002015-12-15
00848665005356AOS END CAP, TIBIAL NAIL COMPRESSIONS11162015-12-15
00848665005363AOS SPACER, STATIC LOCKING TIBIAL NAILS11172015-10-14
00848665005745AOS FRACTURE REDUCTION SCREW HUMERAL NAILS11752015-10-12
00848665012521AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mmS1322-0052015-10-19
00848665012538AOS END CAP, ANTEGRADE FEMORAL NAIL 10.0mmS1322-0102015-12-18
00848665012545AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mmS1322-0152015-12-18
00848665012552AOS LOCKING END CAP, ANTEGRADE FEMORAL NAIL 0mmS13232015-12-18
00848665012569AOS END CAP, ANTEGRADE FEMORAL NAIL 0mmS13242015-12-18
00848665012576AOS SCREW SPACER/COMPRESSION BOLT S13262015-12-18
00848665013832AOS SET SCREW, A/R S10852015-12-04
00848665016536AOS END CAP, TIBIAL NAIL 5mm1115-0502015-10-26
00848665016543AOS END CAP, TIBIAL NAIL 10mm1115-1002015-10-26

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