FDA.report

AOS Screw Capturing Rod, Distal Targeting Tibial Nail

Primary DI
00848665013344
Brand
AOS Screw Capturing Rod, Distal Targeting Tibial Nail
Company
ADVANCED ORTHOPEDIC SOLUTIONS INC
Model
0436
Published
2015-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848665013344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665013344008486650133448486650133440848665013344

GMDN Terms

TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
117858154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00848665027679COUNTERSINK4006-0002020-06-15
00848665000658AOS Drill, AO Style, 2.9mm x 100mm02242020-05-20
00848665001235AOS CANCELLOUS TAP 3.5mm02552020-05-21
00848665027624SUPRAPATELLAR TIBIAL ENTRY SHEATH06422020-05-20
00848665028041T10 Screwdriver, Short50252020-05-20
008486650280963.5mm Calibrated Drill40252020-05-20
00848665028119AOS 2.6mm Solid Reamer40212020-05-20
00848665028782T10 Screwdriver, Solid50202020-05-20
00848665028850AOS SMALL BONE REAMER Ø3.1 x 328mm4020-0312020-05-20
00848665028867AOS SMALL BONE REAMER Ø3.7 x 328mm4020-0372020-05-20
00848665028874AOS SMALL BONE REAMER Ø4.1 x 328mm4020-0412020-05-21
00848665028881AOS SMALL BONE REAMER Ø5.1 x 328mm4020-0512020-05-20
00848665028935Calibrated Drill, AO Style, 2.5mm x 200mm40162020-05-20
00848665028942Calibrated Drill, AO Style, 2.0mm x 200mm40172020-05-20
008486650292152.7mm Calibrated Drill40262020-05-20
008486650300374.0mm CORTICAL TAP (AO STYLE)40292020-05-21
00848665030051AOS T10 SCREWDRIVER, AO STYLE5008-1002020-05-21
00848665030075AOS Cannulated Drill, 2.75mm, Ankle Plate4010-1002020-05-20
00848665030099AOS DRILL, Ø2.8mm4009-1002020-05-20
00848665030105QUICK DRILL, Ø1.9mm40282020-05-20

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