FDA.reportPublic FDA data

General Instruments

Primary DI
00810198920345
Brand
General Instruments
Company
TheraMicro, LLC
Model
2509DK50
Device description
Tunnelling Drill Kit, 5.0mm
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00810198920345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810198920345008101989203458101989203450810198920345

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Regulatory Flags#

DUNS number
133029114
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810198920192TeKBrace solo2510S0182026-09-22
00810198920352TeKForce2471K0122026-08-18
00810198920376TeKForce2514K0012026-08-18
00810198920178TeKBrace2509K0322026-08-14
00810198920086TekBrace2470K0122026-04-17
00810198920093TekBrace2470K0252026-04-17
00810198920109TekBrace2508K0082026-04-17
00810198920116TekBrace2470E3902026-04-17
00810198920123TekBrace2470E4752026-04-17
00810198920130TekBrace Solo2508S0082026-04-17
00810198920147TekBrace2470A3902026-04-17
00810198920154TekBrace2470A4752026-04-17
00810198920161TekBrace2470A5502026-04-17
00810198920222TekBrace2470K2122026-04-17
00810198920239TekBrace2470K2252026-04-17
00810198920246TekBrace2513K1252026-04-17
00810198920253TekBrace2509K0252026-04-17
00810198920260TekBrace2470E5502026-04-17
00810198920307TeKForce2471A0122026-04-17
00810198920314TeKForce2471A0152026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21