FDA.reportPublic FDA data

NA

Primary DI
H9804880660
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
488.066
Catalog number
488066
Device description
TI LOW PROFILE NEURO MACHINE SCREW 3MM
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
K033868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033868000SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTSSynthes (Usa)2004-06-21GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587056067PrimaryGS10
H9804880660SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705606710887587056067

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

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

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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
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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
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00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
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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
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00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
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