FDA.reportPublic FDA data

OneLIF™

Primary DI
G070SPX0150010000020
Brand
OneLIF™
Company
Novapproach Spine LLC
Model
SPX-015-001-0000-02
Catalog number
SPX-015-001-0000-02
Device description
Special Instrument - Straight Inserter Assembly - Wire
Published
2025-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G070SPX0150010000020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059260001
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G070SPX01505400000OneLIF™SPX-015-054-0000SPX-015-054-00002026-09-29
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
G070010307100620OneLIF™010-307-1006-2010-307-1006-22023-04-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.OVD2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCOVD2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217355CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19