510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Intrinsic Therapeutics, Inc.

Woburn, MA, US

Intrinsic Therapeutics, Inc. appears in FDA device records in Woburn, MA. FDA records list one 510(k) clearance, 12 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
12
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Intrinsic Therapeutics, Inc. in 2020.

Clearances by year, as a table
510(k) clearance decisions for Intrinsic Therapeutics, Inc., by decision year
YearClearances
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K201676Barricaid Instrument TrayQHGSubstantially Equivalent

Registered establishments

FDA registered establishments for Intrinsic Therapeutics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30062320633006232063Intrinsic Therapeutics, Inc.30 Commerce Way, Woburn, MA 01801 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2688-2024Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-AAt least two units have been found to be missing a weld.Class IIOpen, Classified
Z-2798-2020Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain