FDA.report

OsteoMed

Primary DI
00845694011822
Brand
OsteoMed
Company
OSTEOMED LLC
Model
375-0009
Catalog number
375-0009
Device description
Hemi Great Toe Implant Trial, Extra Small
Published
2016-07-21
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

Contact Domains

Product Codes

CodeName
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694011822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694011822008456940118228456940118220845694011822

GMDN Terms

TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Device Sizes

TypeValueUnit
Width17.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635273Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635280Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635297Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635303Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635310Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635327Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635334Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635341Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635358Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850005618102BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618119BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618126BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618133BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850005618140BioPoly® Lesser Toe Hemiarthroplasty ImplantBiopoly, LLCKWD2023-10-25
00850044114894Accu-JointAccufix Surgical, Inc.KWD2023-09-11
00850044114900Accu-JointAccufix Surgical, Inc.KWD2023-09-11
00850044114917Accu-JointAccufix Surgical, Inc.KWD2023-09-11
00840097505220restor3d MTPRestor3dKWD2023-04-03
00840097505237restor3d MTPRestor3dKWD2023-04-03
00840097505244restor3d MTPRestor3dKWD2023-04-03