FDA.reportPublic FDA data

X-Pac

Primary DI
00853954003326
Brand
X-Pac
Company
SPINE VIEW, INC.
Model
SV2462
Catalog number
SV2462
Device description
Spine View 12mm Cage Trial
Published
2016-09-24
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
K152539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152539000SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.2016-02-24MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853954003326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853954003326008539540033268539540033260853954003326

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5107435090mmuthini@spineview.com

Regulatory Flags#

DUNS number
787239057
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853954003180X-PacSV2448LSV2448L2016-09-24
00853954003197X-PacSV2448PSV2448P2016-09-24
00853954003203X-PacSV2449PSV2449P2016-09-24
00853954003210X-PacSV2449LSV2449L2016-09-24
00853954003227X-PacSV2451SV24512016-09-24
00853954003234X-PacSV2452SV24522016-09-24
00853954003241X-PacSV2453SV24532016-09-24
00853954003258X-PacSV2455SV24552016-09-24
00853954003265X-PacSV2456SV24562016-09-24
00853954003272X-PacSV2457SV24572016-09-24
00853954003289X-PacSV2458SV24582016-09-24
00853954003296X-PacSV2459SV24592016-09-24
00853954003302X-PacSV2460SV24602016-09-24
00853954003319X-PacSV2461SV24612016-09-24
00853954003333X-PacSV2463SV24632016-09-24
00853954003340X-PacSV2464SV24642016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
18257200076871FORZAOrthofix US LLCMAX2026-07-17
18257200076888FORZAOrthofix US LLCMAX2026-07-17
18257200076895FORZAOrthofix US LLCMAX2026-07-17
18257200076901FORZAOrthofix US LLCMAX2026-07-17
18257200076918FORZAOrthofix US LLCMAX2026-07-17
18257200076925FORZAOrthofix US LLCMAX2026-07-17
18257200077007FORZAOrthofix US LLCMAX2026-07-17
18257200077038FORZAOrthofix US LLCMAX2026-07-17
18257200106028FORZAOrthofix US LLCMAX2026-07-17
18257200106035FORZAOrthofix US LLCMAX2026-07-17
18257200106042FORZAOrthofix US LLCMAX2026-07-17
18257200106066FORZAOrthofix US LLCMAX2026-07-17
18257200106073FORZAOrthofix US LLCMAX2026-07-17
18257200106080FORZAOrthofix US LLCMAX2026-07-17
18257200106097FORZAOrthofix US LLCMAX2026-07-17
18257200106103FORZAOrthofix US LLCMAX2026-07-17
18257200106141FORZAOrthofix US LLCMAX2026-07-17
18257200106158FORZAOrthofix US LLCMAX2026-07-17
18257200109432FORZA PTCOrthofix US LLCMAX2026-07-17
18257200136056FORZA XPOrthofix US LLCMAX2026-07-17
18257200136063FORZA XPOrthofix US LLCMAX2026-07-17
18257200136070FORZA XPOrthofix US LLCMAX2026-07-17
18257200151769FORZA TiOrthofix US LLCMAX2026-07-17