FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123200702
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
35-0383
Device description
LAMBOTTE MINI OSTEO 5 CVD 6MM
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123200702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200702008101232007028101232007020810123200702

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. 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, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. 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
830141235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810220800089Adler Instrument Company38-4985CC2026-05-26
00810220800102Adler Instrument CompanyAD4740002026-05-26
00810220800157Adler Instrument Company27-01002026-05-26
00810220800164Adler Instrument Company200-2822026-05-26
00810220800171Adler Instrument CompanyAD22-11552026-05-26
00810220800188Adler Instrument Company22-11002026-05-26
00810220800195Adler Instrument Company54-22322026-05-26
00810220800201Adler Instrument Company46-00902026-05-26
00810220800218Adler Instrument Company46-00932026-05-26
00810220800225Adler Instrument Company22-51802026-05-26
00810220800232Adler Instrument Company20-22112026-05-26
00810220800249Adler Instrument Company24-61372026-05-26
00810220800256Adler Instrument Company420-1392026-05-26
00810220800270Adler Instrument Company410-2802026-05-26
00810220800287Adler Instrument Company410-2832026-05-26
00810123209996Adler Instrument Company46-8522026-03-17
00810220800003Adler Instrument Company100-2702026-03-17
00810220800010Adler Instrument Company38-52192026-03-17
00810220800027Adler Instrument Company30-02182026-03-17
00810220800034Adler Instrument Company34-00982026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800270Adler Instrument CompanyAdler, Inc.HWM2026-05-26
00810220800287Adler Instrument CompanyAdler, Inc.HWM2026-05-26
10885862663238N/AExactech, Inc.HWM2026-03-19
00190776417796MillenniumAvalign Technologies, Inc.HWM2026-03-11
00190776417802MillenniumAvalign Technologies, Inc.HWM2026-03-11
M9307867516310Life InstrumentsLife Instrument CorporationHWM2026-03-06
00840319758861Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00840319758878Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00190776417611MillenniumAvalign Technologies, Inc.HWM2026-03-04
04046826118327MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
04046826118341MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
03662663109598Mergence-A Preparation InstrumentationHighridge Medical, LLCHWM2026-02-11
03662663131780Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWM2026-02-11
10886982361295NASynthes GmbHHWM2026-02-11
00840277133243Innomed, Inc.INNOMED, INC.HWM2026-02-06
00840277133250Innomed, Inc.INNOMED, INC.HWM2026-02-06
03662663084079ActivLHighridge Medical, LLCHWM2026-02-03
00190776415464MillenniumAvalign Technologies, Inc.HWM2026-01-27
03662663155786Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663155809Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663216005Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216012Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216241Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216258Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216265Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216319Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216326Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216333Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216340Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216357Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17