FDA.reportPublic FDA data

NA

Primary DI
H9804601000
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
460.100
Catalog number
460100
Device description
TI CRANIAL FLAP TUBE CLAMP 11MM DIA
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
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992000000SYNTHES CRANIAL FLAP TUBE CLAMPSynthes (Usa)1999-07-20GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587055299PrimaryGS10
H9804601000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705529910887587055299

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
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
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
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-07
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-06
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210570METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216206METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216312METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216329METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751216336METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05