FDA.reportPublic FDA data

DHS

Primary DI
H6792818300
Brand
DHS
Company
Synthes GmbH
Model
281.830
Catalog number
281830
Device description
150 DEG DHS® PLATE-SHORT BARREL 3 HOLES/62MM
Published
2015-09-14
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791619000DYNAMIC HIP SCREWSynthes (Usa)1979-08-28KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982177865PrimaryGS10
H6792818300SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698217786510886982177865

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982174994DHSSynthes GmbHJDO2015-09-14
10886982175007DHSSynthes GmbHJDO2015-09-14
10886982175014DHSSynthes GmbHJDO2015-09-14
10886982175021DHSSynthes GmbHJDO2015-09-14
10886982175038DHSSynthes GmbHJDO2015-09-14
10886982175045DHSSynthes GmbHJDO2015-09-14
10886982175052DHSSynthes GmbHJDO2015-09-14
10886982175069DHSSynthes GmbHJDO2015-09-14
10886982175076DHSSynthes GmbHJDO2015-09-14
10886982175083DHSSynthes GmbHJDO2015-09-14
10886982175090DHSSynthes GmbHJDO2015-09-14
10886982175106DHSSynthes GmbHJDO2015-09-14
10886982175113DHSSynthes GmbHJDO2015-09-14
10886982175120DHSSynthes GmbHJDO2015-09-14
10886982175137DHSSynthes GmbHJDO2015-09-14
10886982175144DHSSynthes GmbHJDO2015-09-14
10886982175151DHSSynthes GmbHJDO2015-09-14
10886982175168DHSSynthes GmbHJDO2015-09-14
10886982175175DHSSynthes GmbHJDO2015-09-14
10886982175182DHSSynthes GmbHJDO2015-09-14
10886982175212DHSSynthes GmbHJDO2015-09-14
10886982175229DHSSynthes GmbHJDO2015-09-14
10886982175236DHSSynthes GmbHJDO2015-09-14
10886982175243DHSSynthes GmbHJDO2015-09-14
10886982175250DHSSynthes GmbHJDO2015-09-14
10886982175267DHSSynthes GmbHJDO2015-09-14
10886982175274DHSSynthes GmbHJDO2015-09-14
10886982175281DHSSynthes GmbHJDO2015-09-14
10886982175298DHSSynthes GmbHJDO2015-09-14
10886982175304DHSSynthes GmbHJDO2015-09-14