FDA.reportPublic FDA data

Barricaid® ACD (Annular Closure Device)

Primary DI
M906BARA88MM0
Brand
Barricaid® ACD (Annular Closure Device)
Company
INTRINSIC THERAPEUTICS, INC.
Model
8mm width
Catalog number
BAR-A8-8MM
Device description
Barricaid® Annular Closure Device (ACD), 8mm width/size
Published
2019-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QESReherniation Reduction Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QESReherniation Reduction DeviceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160050000BARRICAID ANULAR CLOSURE DEVICE (ACD)Intrinsic Therapeutics2019-02-08QES

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M906BARA88MM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intervertebral disc prolapse repair implantAn implantable device intended to treat a prolapsed lumbar intervertebral disc by repairing the defect in the annulus fibrosus for the prevention of recurrent herniation of the nucleus pulposus. It consists of a mesh plug used to replace the disrupted segment of the annulus, and an attached anchor used to stabilize the plug by fixation to the adjacent vertebral body. It is made of polymer and metallic materials and implanted during a posterior approach procedure. Disposable devices associated with deployment (e.g., pusher, sheath) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
105722131
Device count
1
Lot or batch
true
Serial number
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
M906BARIMPACTOR0Barricaid® ACD Impactor400906-ABAR-IMPACTOR2020-02-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M906KITD7NARROW0Barricaid® Narrow Anchor ACD - Reusable Instruments KitINTRINSIC THERAPEUTICS, INC.QES2026-01-15
M906AT10NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (10mm)INTRINSIC THERAPEUTICS, INC.QES2026-01-15
M906AT8NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (8mm)INTRINSIC THERAPEUTICS, INC.QES2026-01-15
M906BARA610MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)INTRINSIC THERAPEUTICS, INC.QES2026-01-15
M906BARA68MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)INTRINSIC THERAPEUTICS, INC.QES2026-01-15
M906BARA810MM0Barricaid® ACD (Annular Closure Device)INTRINSIC THERAPEUTICS, INC.QES2019-05-14