FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528123317
Brand
OsteoMed
Company
OSTEOMED LLC
Model
218-3195-SP
Catalog number
218-3195-SP
Device description
SmartFlex Spring NC- 9.5N
Published
2019-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBJCranial Distraction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBJCranial Distraction SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528123317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528123317008425281233178425281233170842528123317

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorAn implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118149367DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2025-09-24
00888118136589DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136596DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136626DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136633DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136640DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136657DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
10887587071817NASynthes GmbHPBJ2019-12-12
10887587071824NASynthes GmbHPBJ2019-12-12
10887587071831NASynthes GmbHPBJ2019-12-12
10887587071848NASynthes GmbHPBJ2019-12-12
10887587071855NASynthes GmbHPBJ2019-12-12
10887587071923NASynthes GmbHPBJ2019-12-12
10887587071930NASynthes GmbHPBJ2019-12-12
10887587071947NASynthes GmbHPBJ2019-12-12
10887587071954NASynthes GmbHPBJ2019-12-12
10887587072388NASynthes GmbHPBJ2019-12-12
10887587072395NASynthes GmbHPBJ2019-12-12
10887587072401NASynthes GmbHPBJ2019-12-12
10887587072418NASynthes GmbHPBJ2019-12-12
10887587072425NASynthes GmbHPBJ2019-12-12
10887587072517NASynthes GmbHPBJ2019-12-12
10887587072524NASynthes GmbHPBJ2019-12-12
10887587072531NASynthes GmbHPBJ2019-12-12
10887587072548NASynthes GmbHPBJ2019-12-12
10887587072555NASynthes GmbHPBJ2019-12-12
20887587071869NASynthes GmbHPBJ2019-12-12
20887587071876NASynthes GmbHPBJ2019-12-12
20887587071883NASynthes GmbHPBJ2019-12-12
20887587071890NASynthes GmbHPBJ2019-12-12