FDA.reportPublic FDA data

ACF

Primary DI
10705034774350
Brand
ACF
Company
Synthes GmbH
Model
389.078
Catalog number
389078
Device description
SPN CORRECTION ACF EXTENDED IMPLANT HOLDER
Published
2016-12-31
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
HYAFORCEPS, WIRE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034774350PrimaryGS10
H9813890780SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477435010705034774350

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
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
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603753094LAZICPeter Lazic GmbHHYA2026-03-25
04250603753100LAZICPeter Lazic GmbHHYA2026-03-25
00194613028886MSI Precision Specialty InstrumentsMed Saver, Inc.HYA2025-08-01
03760225714096In2BonesIN2BONESHYA2024-12-13
04250603748526LAZICPeter Lazic GmbHHYA2024-11-20
04250603749295LAZICPeter Lazic GmbHHYA2024-11-20
03700569626877Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
03700569626884Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
04049197473248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
04049197473255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
00840183516758BR Surgical, LLCBR Surgical, LLCHYA2024-06-03
00840180519301General InstrumentsALPHATEC SPINE, INC.HYA2023-09-22
07898506853717QuinelatoSchobell Industrial LtdaHYA2023-07-07
07898506848676QuinelatoSchobell Industrial LtdaHYA2023-07-05
07898506814312QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853601QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853618QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853625QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853649QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853724QuinelatoSchobell Industrial LtdaHYA2022-12-16
07899798203310SchobellSchobell Industrial LtdaHYA2022-11-28
00840180508336General InstrumentsALPHATEC SPINE, INC.HYA2022-10-13
00887482055410Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HYA2022-08-25
00850027837642StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
00850027837659StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
04250603736608LAZICPeter Lazic GmbHHYA2021-12-22
04250603739487LAZICPeter Lazic GmbHHYA2021-12-22
00850027837529StabilICEACUTUS MEDICAL, INC.HYA2021-10-28
04250603736103LAZICPeter Lazic GmbHHYA2021-07-02
04250603736110LAZICPeter Lazic GmbHHYA2021-07-02