FDA.reportPublic FDA data

OneLIF™

Primary DI
G070SPX01505400000
Brand
OneLIF™
Company
Novapproach Spine LLC
Model
SPX-015-054-0000
Catalog number
SPX-015-054-0000
Device description
Special Instrument - Extraction Tool
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G070SPX01505400000PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
059260001
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
G07001313112180OneLIF™013-131-1218013-131-12182023-02-06

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