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

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
G070SPX01505300000OneLIF™SPX-015-053-0000SPX-015-053-00002026-10-30
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
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08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
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08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
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08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858707Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
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