FDA.reportPublic FDA data

NA

Primary DI
10886982287861
Brand
NA
Company
Synthes GmbH
Model
SD398.760
Catalog number
SD398760
Device description
COLLINEAR REDUCTION CLAMP ROTATIONAL ATTACHMENT
Published
2019-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982287861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698228786110886982287861

GMDN Terms#

Term, Definition table
TermDefinition
Temporal bone holderA surgical device used to hold a piece of bone in a clamped position outside of the surgical field while the surgeon and/or other helping assistants work on it. It is typically used to reshape bone or for creating grafting material. This device will typically have a sturdy foot, a clamp to hold the bone, and an integral dish-like bowl to catch the bone fragments/cuttings. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400460MillenniumAvalign Technologies, Inc.HTD2026-07-21
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD91705525T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9183761030Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184571000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184932000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
00810158219960PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219977PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219991PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850088713008PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00810158210837PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211100PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211117PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23