FDA.reportPublic FDA data

Excella®

Primary DI
M711LA1130
Brand
Excella®
Company
INNO Holdings, Inc.
Model
LA-113
Device description
Pedicle Marker, Cone, Excella-P, SST
Published
2024-01-31
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LA1130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal intraoperative positioning pin, reusableA nonimplantable thin rod intended to be temporarily introduced, with a dedicated inserter (not included), into vertebral bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. This is a reusable device.

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
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
00840606191302PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00840606191319PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
B382SD4838920Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10888857578197Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578203Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578630Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578647Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578654Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578661Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578678Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578685Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20