FDA.reportPublic FDA data

EIT PLIF Distractor

Primary DI
04260557776063
Brand
EIT PLIF Distractor
Company
EIT Emerging Implant Technologies GmbH
Model
PET91203
Device description
Lordotic Trial Distractor, H 12mm, 18°, 22/6
Published
2018-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04260557776063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260557776063042605577760634260557776063

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
00889929072219NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072226NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072233NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072264NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072271NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072288NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072295NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072301NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072318NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072325NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072332NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072349Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072356NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072363NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072394NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17