FDA.reportPublic FDA data

EIT PLIF Shaver

Primary DI
04260397088432
Brand
EIT PLIF Shaver
Company
EIT Emerging Implant Technologies GmbH
Model
PET11101
Device description
Endplate Shaver, H 11mm
Published
2018-09-21
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
04260397088432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260397088432042603970884324260397088432

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
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00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
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04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
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04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
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