FDA.reportPublic FDA data

restor3d Lumbar Instrument

Primary DI
00840097506555
Brand
restor3d Lumbar Instrument
Company
Restor3d, Inc.
Model
5113-S1415
Device description
Lumbar ALIF Trial, Small Footprint, 14mm Height, 15°
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097506555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097506555008400975065558400975065550840097506555

GMDN Terms#

Term, Definition table
TermDefinition
Assistive laundry clotheslineA technical laundry aid designed to be used by a person with a disability upon which they can hang wet or damp clothing for this to dry. It is designed as a flexible line that can be horizontally tensioned upon which the clothing is hung. It typically consists of several parallel lines held within a holder that is affixed to a wall; the loose end is stretched to a second anchorage point on an adjacent wall when in use. It is typically folded together for convenient storage when not in use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097536705Identity CR KA5253-0001TCR-000- D0012026-09-25
00840097536712Identity CR KA5253-0002TCR-000- D0012026-09-25
00840097536729Identity CR KA 3DP Porous5253-0031TCR-000-D0052026-09-25
00840097536736Identity CR KA 3DP Porous5253-0032TCR-000-D0052026-09-25
00840097536743Identity CR KA 3DP Porous5253-0021TCR-000-SPEC2026-09-25
00840097536750Identity CR KA 3DP Porous5253-0011TCR-000-SPEC2026-09-25
00840097536767Identity CR KA 3DP Porous5253-0022TCR-000-SPEC2026-09-25
00840097536774Identity CR KA 3DP Porous5253-0012TCR-000-SPEC2026-09-25
00840097536781Identity CR KA5253-0901TCR-000-D0012026-09-25
00840097536798Identity CR KA5253-0902TCR-000-D0012026-09-25
00840097536804Identity CR KA 3DP Porous5253-0933TCR-000-D0052026-09-25
00840097536811Identity CR KA 3DP Porous5253-0934TCR-000-D0052026-09-25
00840097533919Veritas Hemiarthroplasty1508-10012026-09-18
00840097533926Veritas Hemiarthroplasty1510-38142026-09-18
00840097533933Veritas Hemiarthroplasty1510-40152026-09-18
00840097533940Veritas Hemiarthroplasty1510-42162026-09-18
00840097533957Veritas Hemiarthroplasty1510-44172026-09-18
00840097533964Veritas Hemiarthroplasty1510-46182026-09-18
00840097533971Veritas Hemiarthroplasty1510-48182026-09-18
00840097533988Veritas Hemiarthroplasty1510-50192026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03