FDA.reportPublic FDA data

Bone Chisel

Primary DI
00810131880729
Brand
Bone Chisel
Company
Surgentec, LLC
Model
SR99-6003
Published
2024-12-10
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
00810131880729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131880729008101318807298101318807290810131880729

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
004095409
Device count
1
Premarket exempt
true
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
00810131882983BMAN BCOR Bone Marrow Aspirate KitAAN-09-BCORES2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)AAN-09-BCORE2026-08-19
00810131885045ION Non CervicalSR17-10002026-07-28
00810131881795ION Disposable Instrument KitTI-K-10002026-03-09
00810131881801ION 55 Facet Implant - SterileTI-K-552026-03-09
00810131881818ION 60 Facet Implant - SterileTI-K-602026-03-09
00810131881825ION 65 Facet Implant - SterileTI-K-652026-03-09
00810131882433ION-C Navigation LocatorSR12-25122026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSR12-65102026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSR12-65112026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSR12-65092026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSR21-63052026-07-06
00810131882556TiLink-L Navigation Drill GuideSR21-63012026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSR21-63042026-07-06
00810131882617TiLink-L Navigation Impact CapSR21-63032026-07-06
00810131882761Facet Sterile Implant - 55FI-S-552026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalFIC-10002026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSR12-27002026-07-06
00810131883669Ion Navigation Inserter AOSR12-65012026-07-06
00810131884772ION-C Final KitTI-C-10002026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
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00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26