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
00840097536668Veritas rTSA Instrumentation5500-32022026-06-25
00840097535678Veritas rTSA3500-142U12026-06-03
00840097535692Veritas rTSA3500-142C12026-06-03
00840097535715Veritas rTSA3500-142U32026-06-03
00840097535739Veritas rTSA3500-142C32026-06-03
00840097535753Veritas rTSA3500-342U12026-06-03
00840097535777Veritas rTSA3500-342C12026-06-03
00840097535791Veritas rTSA3500-342U32026-06-03
00840097535814Veritas rTSA3500-342C32026-06-03
00840097535838Veritas rTSA3500-542U12026-06-03
00840097535852Veritas rTSA3500-542C12026-06-03
00840097535876Veritas rTSA3500-542U32026-06-03
00840097535890Veritas rTSA3500-542C32026-06-03
00840097534978Veritas rTSA1501-42012026-06-02
00840097534985Veritas rTSA1501-42042026-06-02
00840097513218Veritas rTSA1500-10152026-05-14
00840097513225Veritas rTSA1500-10302026-05-14
00840097513232Veritas rTSA1500-10352026-05-14
00840097513249Veritas rTSA1500-10452026-05-14
00840097532356Veritas rTSA Instrumentation6500-20472026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09