FDA.reportPublic FDA data

Barricaid® ACD Impactor

Primary DI
M906BARIMPACTOR0
Brand
Barricaid® ACD Impactor
Company
INTRINSIC THERAPEUTICS, INC.
Model
400906-A
Catalog number
BAR-IMPACTOR
Device description
Single-use disposable surgical instrument to aid in insertion of the Barricaid® Annular Closure Device (ACD), in the event that additional impaction is necessary.
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
M906BARIMPACTOR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781.932.0222info@in-thera.com

Regulatory Flags#

DUNS number
105722131
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M906KITD7NARROW0Barricaid® Narrow Anchor ACD - Reusable Instruments Kit4001009KIT-D7-NARROW2026-01-15
M906AT10NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (10mm)400944AT-10-NARROW2026-01-15
M906AT8NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (8mm)400943AT-8-NARROW2026-01-15
M906BARA610MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2741015-A6BAR-A6-10MM2026-01-15
M906BARA68MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2740815-A6BAR-A6-8MM2026-01-15
M906WED1A0Barricaid ACD Retraction Wedge400846WED-1-A2019-05-14
M906KITD70Barricaid® ACD - Reusable Instruments Kit4001007KIT-D72021-02-15
M906BARAT100Barricaid® ACD Alignment Trial (10mm)400877BAR-AT-102020-02-04
M906BARAT80Barricaid® ACD Alignment Trial (8mm)400879BAR-AT-82020-02-04
M906BARDMT10X110Defect Measurement Tool (10/11mm)400212BAR-DMT-10X112020-02-04
M906BARDMT12X130Defect Measurement Tool (12/13mm)400213BAR-DMT-12X132020-02-04
M906BARDMT4X50Defect Measurement Tool (4/5mm)400209BAR-DMT-4X52020-02-04
M906BARDMT6X70Defect Measurement Tool (6/7mm)400210BAR-DMT-6X72020-02-04
M906BARDMT8X90Defect Measurement Tool (8/9mm)400211BAR-DMT-8X92020-02-04
M906BARMALLET0Surgical Mallet (Slotted)400929BAR-MALLET2020-02-04
M906BARWEDGE0Barricaid® ACD Retraction Wedge400846BAR-WEDGE2020-02-04
M906KITD4C10Barricaid® ACD - Reusable Instruments Kit (Tray Only)400885KIT-D4-C12020-02-04
M906KITD40Barricaid® ACD - Reusable Instruments Kit4001004KIT-D42019-05-14
M906DMT10X11A0Defect Measurement Tool (10/11mm)400212DMT-10X11-A2019-05-14
M906DMT12X13A0Defect Measurement Tool (12/13mm)400213DMT-12X13-A2019-05-14

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