DEVICE: OneLIF™ (G07001505000000)

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Device Record History
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Device Identifier (DI) Information
OneLIF™
015-050-0000
In Commercial Distribution
015-050-0000
Novapproach Spine LLC
G07001505000000
HIBCC

1
059260001 *Terms of Use
Fixed Angled Screwdriver Housing
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64192 Internal spinal fixation procedure kit, reusable
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MAX Intervertebral fusion device with bone graft, lumbar
OVD Intervertebral fusion device with integrated fixation, lumbar
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K211769 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
980f51a7-099c-4543-bb34-b2c6be89931b
March 12, 2026
1
March 04, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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