FDA.reportPublic FDA data

L-Varlock

Primary DI
00850011324097
Brand
L-Varlock
Company
SPINESOURCE INC
Model
097
Catalog number
SD-4100
Device description
Instrument, Expansion Screwdriver, Long
Published
2019-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850011324097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011324097008500113240978500113240970850011324097

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
150955560
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011324158L-Varlock158VAL-CA-13-092021-06-03
00850011324165L-Varlock165VAL-CA-13-112021-06-03
00850011324134L-Varlock134VAL-CA-13-132020-11-24
00850011324141L-Varlock141HD00642020-12-02
00850011324028L-Varlock028DS-1072019-08-22
00850011324035L-Varlock035DS-1082019-08-22
00850011324042L-Varlock042DS-1092019-08-22
00850011324059L-Varlock059DS-1102019-08-22
00850011324066L-Varlock066DS-1112019-08-22
00850011324073L-Varlock073DS-1122019-08-22
00850011324080L-Varlock080DS-1132019-08-22
00850011324127L-Varlock127SP-0022020-01-22
00850011324110L-Varlock110VAL-CA-10-092019-11-12
00850011324103L-Varlock103HA-0022019-10-11
00850011324004L-Varlock004VAL-CA-13-082019-08-15
00850011324011L-Varlock011SP-0012019-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03