FDA.reportPublic FDA data

Vantage

Primary DI
10885862628824
Brand
Vantage
Company
Exactech, Inc.
Model
03-PNB-MD-0000
Catalog number
03-PNB-MD-0000
Device description
3D+ Modular Distractor
Published
2024-08-28
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862628824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586262882410885862628824

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011177814Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade KitMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177838Wright-Out Hip Stem Extractor Slide HammerMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177845Wright-Out Hip Stem Extractor Osteotome HandleMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177852Wright-Out Hip Stem Extractor 5/64" T-Handle Hex KeyMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177869Wright-Out Hip Stem Extractor 10mm T-Handle Socket WrenchMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
03770019503416Drill - Screw D.3,5mm-L.18SC MEDICALXH2026-07-03
03770019503867Cannulated Screwdriver tip for screw D3,5mm-L.16SC MEDICALXH2026-07-03
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
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