FDA.reportPublic FDA data

X-PAC

Primary DI
00850001720052
Brand
X-PAC
Company
EXPANDING INNOVATIONS, INC.
Model
EI2452
Catalog number
EI2452
Device description
12mm Cage Cannula
Published
2018-11-23
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160856000SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.2016-08-01MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001720052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001720052008500017200528500017200520850001720052

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, reusableA single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
650 861 3129mmuthini@expandinginnovations.com

Regulatory Flags#

DUNS number
081309444
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810166521604X-PACEI26152026-07-30
00810166521611X-PACEI26162026-07-30
00810166521628X-PACEI24672026-07-30
00810166521703X-PACEI26242026-07-30
00810166521765X-PACEI26222026-07-30
00810166523004X-PACEI24802026-07-30
00810166523011X-PACEI24792026-07-30
00810166523028X-PACEI2477EI24512026-07-30
00850001720830X-PACEI30342026-07-30
00850041805863X-PACEI26082026-07-30
00810166522861Expanding InnovationsEI46242026-05-27
00810166522878Expanding InnovationsEI46252026-05-27
00810166522366X-PACEI24732026-05-27
00810166522373X-PACEI24742026-05-27
00810166522809X-PACEI46182026-05-27
00810166522816Expanding InnovationsEI46192026-05-27
00810166522823Expanding InnovationsEI46202026-05-27
00810166522830Expanding InnovationsEI46212026-05-27
00810166522847Expanding InnovationsEI46222026-05-27
00810166522854Expanding InnovationsEI46232026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30