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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29