FDA.reportPublic FDA data

NA

Primary DI
H980446054S0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
446.054S
Catalog number
446054S
Device description
1.5MM TI CONTOURABLE MESH PL RIGID/70MM DIA-STERILE
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0331210001.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATESSynthes (Usa)2003-10-20JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587051475PrimaryGS10
H980446054S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705147510887587051475

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

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
832637081
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351389TRUMATCHMaterialise NVJEY2026-10-22
05420060351396TRUMATCHMaterialise NVJEY2026-10-22
05420060351402TRUMATCHMaterialise NVJEY2026-10-22
00888118150288LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150295LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150301LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150318LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150325LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150332LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150349LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150356LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150363LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150370LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150387LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150394LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21