FDA.reportPublic FDA data

OSTEOTOME

Primary DI
00888118064035
Brand
OSTEOTOME
Company
KLS-Martin L.P.
Model
38-807-15-07
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00888118064035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118064035008881180640358881180640350888118064035

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

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