FDA.reportPublic FDA data

OSSIO Drill Bit, 5.9mm Cannulated (1058)

Primary DI
00850078396334
Brand
OSSIO Drill Bit, 5.9mm Cannulated (1058)
Company
Eca Medical Instruments
Model
1058
Catalog number
1058
Published
2026-08-14
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
00850078396334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078396334008500783963348500783963340850078396334

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
084330422
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)105410542026-08-18
00850078396341OSSIO 6.0mm Cannulated Drill Bit( 1059)105910592026-08-14
00850078396358OSSIO 6.1mm Cannulated Drill Bit(1060)106010602026-08-14
00857676008546LINQ Surgery Ready Instrument SystemLQG39652024-02-16
008500783961982.2 TITAN Nail Instrument KitF15-A-2784S1047-0012026-06-23
008500783962043.0 TITAN Nail Instrument KitF15-A-2884S1047-0022026-06-23
008500783962284.0 TITAN Nail Instrument KitF15-A-8004.30S1047-0032026-06-23
008500783962352.2-4.0 TITAN Nail SizerF15-A-2084S10482026-06-23
008500783962422.2 TITAN Nail Accessory KitF15-A-2785S1049-0012026-06-23
008500783962593.0 TITAN Nail Accessory KitF15-A-2885S1049-0022026-06-23
008500783962734.0 TITAN Nail Accessory KitF15-A-8004.31S1049-0032026-06-23
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)228-TXRX-006228-TXRX-0062026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)228-TXRX-007228-TXRX-0072026-06-05
00857676008911IM NAIL PERCUTANEOUS DEPTH GAUGE STERILE (1043)104310432026-04-02
00850078396105IM NAIL DISPOSABLE HANDLE STERILE (1044)104410442026-03-10
00857676008812IM NAIL FRACTURE REDUCTION GUIDE STERILE (1012)10122025-06-17
00857676008874TruTORQ Medium Axial Handle, Sterile, Single Use, With T8101010102026-02-25
00850078396082TruPWR Torque Limiting Attachment Sterile, Single Use 11.3Nm228-TXRX-005228-TXRX-0052026-02-04
00850078396129TransLoc 3D, Depth Gauge for All-Metal Introducer103010302026-01-21
00850078396136iFuse INTRA Ti Instrument Kit102910292026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18