FDA.reportPublic FDA data

HAnano InterFuse

Primary DI
00840314193599
Brand
HAnano InterFuse
Company
NEXT ORTHOSURGICAL, INC.
Model
9076-10-20-5-B-HA
Catalog number
9076-10-20-5-B-HA
Device description
Expansion Module B 10x20, 5°
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
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
K242509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242509000HAnano InterFuse(R) Modular InterbodyNext Orthosurgical2024-09-19MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314193599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314193599008403141935998403141935990840314193599

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Length20Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-295-3600Info@nextorthosurgical.com

Regulatory Flags#

DUNS number
046767258
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314141798Nex-D2CBCAJ-10000CBCAJ-100002024-09-16
00840314141804Nex-D2CBCBJ-10000CBCBJ-100002024-09-16
00840314165923Nex-D2CBFBJ-70140CBFBJ-701402024-09-05
00840314165930Nex-D2CBFBJ-70145CBFBJ-701452024-09-05
00840314165947Nex-D2CBFBJ-70150CBFBJ-701502024-09-05
00840314165954Nex-D2CBFBJ-78020CBFBJ-780202024-09-05
00840314165961Nex-D2CBFBJ-78025CBFBJ-780252024-09-05
00840314165978Nex-D2CBFBJ-78030CBFBJ-780302024-09-05
00840314165985Nex-D2CBFBJ-78035CBFBJ-780352024-09-05
00840314165992Nex-D2CBFBJ-78040CBFBJ-780402024-09-05
00840314166005Nex-D2CBFBJ-78045CBFBJ-780452024-09-05
00840314166012Nex-D2CBFBJ-78050CBFBJ-780502024-09-05
00840314166029Nex-D2CBFBJ-78055CBFBJ-780552024-09-05
00840314166036Nex-D2CBFBJ-78060CBFBJ-780602024-09-05
00840314166043Nex-D2CBFBJ-78065CBFBJ-780652024-09-05
00840314166050Nex-D2CBFBJ-78070CBFBJ-780702024-09-05
00840314166067Nex-D2CBFBJ-78075CBFBJ-780752024-09-05
00840314166074Nex-D2CBFBJ-78080CBFBJ-780802024-09-05
00840314166081Nex-D2CBFBJ-78085CBFBJ-780852024-09-05
00840314166098Nex-D2CBFBJ-78090CBFBJ-780902024-09-05

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Primary DI, Brand, Company table
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