FDA.reportPublic FDA data

L-Box®

Primary DI
M711LB1620
Brand
L-Box®
Company
INNO Holdings, Inc.
Model
LB-162
Catalog number
LB-162
Device description
SST
Published
2018-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LB1620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13
B382SD9227021010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92270212C0Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707140Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707150Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707160Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707170Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707180Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707190Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734060Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734070Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734080Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738100Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381000Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381020Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738990Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92274510120Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227771090Surgical DirectSurgical Direct, Inc.HTX2026-07-10
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06