FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528114254
Brand
OsteoMed
Company
OSTEOMED LLC
Model
450-1616
Catalog number
450-1616
Device description
1.6mm Driver Stem, w/ Post, AO Shank, Short
Published
2018-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528114254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528114254008425281142548425281142540842528114254

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.88Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13
00842528129906OsteoMed336-9207336-92072023-10-13
00842528129913OsteoMed336-9208336-92082023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536800244Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
00840536800251Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
07901125600706Minidriver SolarisGM DOS REIS INDUSTRIA E COMERCIO LTDAKIJ2026-02-20
07649988202209FiberLocker PowerUnit - Transfer ShieldZuriMED Technologies AGKIJ2026-02-02
07649988202278FiberLocker PowerUnit - HandpieceZuriMED Technologies AGKIJ2026-02-02
07649988202285FiberLocker PowerUnit - Motor PackZuriMED Technologies AGKIJ2026-02-02
07649988202292FiberLocker PowerUnit - Charging StationZuriMED Technologies AGKIJ2026-02-02
08800038060319EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060326EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060333EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060340EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
00850056900102Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
08800068959348LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959355LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959645LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800017270258BENCOX Surgical InstrumentsCorentec Co., LtdKIJ2025-09-24
08809260475052TD-AUTOSaeshin Precision Co., Ltd.KIJ2025-07-22
008401944934513P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937723P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937893P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944938883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863123P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863293P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321866883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19