FDA.reportPublic FDA data

restor3d Disposable Instrument, Wedge Trial

Primary DI
00840097502748
Brand
restor3d Disposable Instrument, Wedge Trial
Company
Restor3d
Model
6100-002-22140509
Device description
Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 5mm Thickness
Published
2021-07-16
Public version status
New
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
00840097502748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502748008400975027488400975027480840097502748

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, single-useA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00840097502731restor3d Disposable Instrument, Wedge Trial6100-002-221404072021-07-16
00840097502755restor3d Disposable Instrument, Wedge Trial6100-002-221406112021-07-16
00840097502762restor3d Disposable Instrument, Wedge Trial6100-002-221408132021-07-16
00840097502779restor3d Osteotomy Wedge1100-002-221404072021-07-16
00840097502786restor3d Osteotomy Wedge1100-002-221405092021-07-16
00840097502793restor3d Osteotomy Wedge1100-002-221406112021-07-16
00840097502809restor3d Osteotomy Wedge1100-002-221408132021-07-16
00840097500188restor3d Osteotomy Wedge1101-ADAS-00-151606182019-12-16
00840097500195restor3d Osteotomy Wedge1101-ADAS-00-181608182019-12-16
00840097500201restor3d Osteotomy Wedge1101-ADAS-00-181610182019-12-16
00840097500218restor3d Osteotomy Wedge1101-ADAS-00-181612182019-12-16
00840097500225restor3d Osteotomy Wedge1101-ADAS-00-151806182019-12-16
00840097500232restor3d Osteotomy Wedge1101-ADAS-00-201808182019-12-16
00840097500249restor3d Osteotomy Wedge1101-ADAS-00-201810182019-12-16
00840097500256restor3d Osteotomy Wedge1101-ADAS-00-201812182019-12-16
00840097500263restor3d Osteotomy Wedge1101-ADAS-00-152006182019-12-16
00840097500270restor3d Osteotomy Wedge1101-ADAS-00-222008182019-12-16
00840097500287restor3d Osteotomy Wedge1101-ADAS-00-222010182019-12-16
00840097500294restor3d Osteotomy Wedge1101-ADAS-00-222012182019-12-16
00840097500300restor3d Osteotomy Wedge1100-ADAS-00-161404072019-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26