FDA.reportPublic FDA data

EIT ALIF Distractor Forceps

Primary DI
04260557774694
Brand
EIT ALIF Distractor Forceps
Company
EIT Emerging Implant Technologies GmbH
Model
AFT10100
Device description
Offset Distractor Forceps
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170503000EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF CagesEit Emerging Implant Technologies GmbH2017-07-11MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260557774694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260557774694042605577746944260557774694

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
313088331
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260397080221EIT CIF ImpactorCET302012018-01-05
04260397081044EIT CIF ImpactorCET302112018-09-21
04260397081440EIT TLIF ImpactorTET302002018-01-05
04260397087657EIT TLIF ImpactorTET302012018-01-05
04260397088074EIT PLIF Implant PusherPET302002018-01-09
04260557837764EIT LLIF Implant Pusher LET302002018-11-28
04260557770009EIT CIF cageCUI0040S2017-10-17
04260557770016EIT CIF cageCUI0050S2017-10-20
04260557770023EIT CIF cageCUI0060S2017-10-20
04260557770030EIT CIF cageCUI0070S2017-10-20
04260557770047EIT CIF cageCUI0080S2017-10-20
04260557770054EIT CIF cageCUI0090S2017-10-20
04260557770061EIT CIF cageCUI0100S2017-10-20
04260557770078EIT CIF cageCUI0110S2017-10-20
04260557770085EIT CIF cageCUI0120S2017-10-20
04260557770092EIT CIF cageCUI0040L2017-10-20
04260557770108EIT CIF cageCUI0050L2017-10-20
04260557770115EIT CIF cageCUI0060L2017-10-20
04260557770122EIT CIF cageCUI0070L2017-10-20
04260557770139EIT CIF cageCUI0080L2017-10-20

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