FDA.reportPublic FDA data

OneLIF™

Primary DI
G070010307100620
Brand
OneLIF™
Company
Novapproach Spine LLC
Model
010-307-1006-2
Catalog number
010-307-1006-2
Device description
OneLIF Cage, Large, 7 Degree, 10mm X 6mm - Oblique
Published
2023-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211769000OneLIF Intervertebral Body Replacement SystemNovapproach Spine2021-09-07OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G070010307100620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Contacts#

Phone, Email table
PhoneEmail
+1(385)588-3408ron.green@novapproachspine.com

Regulatory Flags#

DUNS number
059260001
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G07001504900000OneLIF™015-049-0000015-049-00002026-03-04
G07001505000000OneLIF™015-050-0000015-050-00002026-03-04
G070SPX01510022120OneLIF™SPX-015-100-2212SPX-015-100-22122025-08-06
G070SPX01510022140OneLIF™SPX-015-100-2214SPX-015-100-22142025-08-06
G070SPX01510022160OneLIF™SPX-015-100-2216SPX-015-100-22162025-08-06
G070SPX01510022180OneLIF™SPX-015-100-2218SPX-015-100-22182025-08-06
G070010107100720OneLIF™010-107-1007-2010-107-1007-22023-04-24
G070010113100620OneLIF™010-113-1006-2010-113-1006-22023-04-24
G070010207100720OneLIF™010-207-1007-2010-207-1007-22023-04-24
G07001200645160OneLIF™012-006-4516012-006-45162023-02-21
G07001200645200OneLIF™012-006-4520012-006-45202023-02-21
G07001200645240OneLIF™012-006-4524012-006-45242023-02-21
G07001200645280OneLIF™012-006-4528012-006-45282023-02-21
G07001200647160OneLIF™012-006-4716012-006-47162023-02-21
G07001200647200OneLIF™012-006-4720012-006-47202023-02-21
G07001200647240OneLIF™012-006-4724012-006-47242023-02-21
G07001200647280OneLIF™012-006-4728012-006-47282023-02-21
G07001313012180OneLIF™013-130-1218013-130-12182023-02-06
G07001313112180OneLIF™013-131-1218013-131-12182023-02-06
G07001323012200OneLIF™013-230-1220013-230-12202023-02-06

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Primary DI, Brand, Company table
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00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14