FDA.reportPublic FDA data

restor3d Disposable Instrument, Wedge Trial

Primary DI
00840097502939
Brand
restor3d Disposable Instrument, Wedge Trial
Company
Restor3d, Inc.
Model
6101-009-20180818
Device description
Disposable Trial, Evans Wedge 009, Medium Footprint, 8mm Thickness
Published
2021-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00840097502939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502939008400975029398400975029390840097502939

Regulatory Flags#

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00840097503011restor3d Osteotomy Wedge1100-002-221409072021-09-01
00840097503028restor3d Osteotomy Wedge1100-002-221410072021-09-01
00840097503073restor3d Osteotomy Wedge1100-002-221405072021-09-01
00840097503080restor3d Osteotomy Wedge1100-002-221406072021-09-01
00840097503097restor3d Osteotomy Wedge1100-002-221407072021-09-01
00840097503103restor3d Osteotomy Wedge1100-002-221408072021-09-01
00840097504674restor3d Osteotomy Wedge1100-002-221405102022-08-18
00840097504681restor3d Osteotomy Wedge1100-002-221406132022-08-18
00840097504698restor3d Osteotomy Wedge1100-002-221407152022-08-18
00840097504704restor3d Osteotomy Wedge1100-002-221408182022-08-18
00840097504711restor3d Osteotomy Wedge1100-002-221410232022-08-18
00840097504728restor3d Osteotomy Wedge1100-002-221412282022-08-18
00840097504735restor3d Osteotomy Wedge1100-002-181205132022-08-18
00840097504742restor3d Osteotomy Wedge1100-002-181206162022-08-18
00840097504759restor3d Osteotomy Wedge1100-002-181207192022-08-18
00840097504766restor3d Osteotomy Wedge1100-002-181208222022-08-18
00840097504773restor3d Osteotomy Wedge1100-002-181210282022-08-18
00840097504780restor3d Osteotomy Wedge1100-002-181212342022-08-18
00840097503110restor3d Disposable Instrument, Wedge Trial6100-NSP-A04052021-11-15
00840097503127restor3d Disposable Instrument, Wedge Trial6100-NSP-A05062021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133632REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133649REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133656REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133670REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133687REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133700REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133731REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
07630699714822Surgical Manual InstrumentMedacta International SALXH2026-11-03
08800424704063VEGA Cervical Screw SystemGS Medical Co., Ltd.LXH2026-11-03
08809974815977Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-11-03
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02