Integra LifeSciences Corporation

Entity profile compiled from public source records

Public Record Profile Registrations: 15 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000138491, 1121308, 3000204775, 3003249645, 3003418325, 3004170064, 3004608878, 3005809810, 3005920706, 3006697299, 3012507533, 3013505638, 3013886523, 3014334038, 3015194982
Owner Operator Numbers 9004007
Locations Covered ANASCO, PR, US; Braintree, MA, US; CINCINNATI, OH, US; Chicago, IL, US; Columbia, MD, US; Irvine, CA, US; Le Locle Neuchatel, CH; Mansfield, MA, US; Oakville Ontario, CA; PLAINSBORO, NJ, US; Princeton, NJ, US; Rietheim-Weilheim Baden-Wurttemberg, DE; SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR; SRAGH TULLAMORE Offaly, IE; West Valley City, UT, US

Registered Establishments (15)

Registration # Establishment Name Location Establishment Type(s) Action
1121308 INTEGRA LIFESCIENCES CORPORATION PLAINSBORO, NJ, US Manufacture Medical Device View Details
1722447 Integra Pain Management West Valley City, UT, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US Manufacture Medical Device View Details
3003418325 Integra LifeSciences Corporation Princeton, NJ, US Complaint File Establishment per 21 CFR 820.198 View Details
3004170064 Integra LifeSciences Braintree Inc. Braintree, MA, US Manufacture Medical Device View Details
3004608878 INTEGRA LIFESCIENCES CORPORATION CINCINNATI, OH, US Repack or Relabel Medical Device View Details
3005809810 Jarit GmbH Rietheim-Weilheim Baden-Wurttemberg, DE Repack or Relabel Medical Device View Details
3005920706 ACELL, INC. Columbia, MD, US Manufacture Medical Device View Details
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE Manufacture Medical Device View Details
3012507533 Integra Canada ULC Oakville Ontario, CA Export Device to the United States But Perform No Other Operation on Device View Details
3013505638 REBOUND THERAPEUTICS, CORPORATION Irvine, CA, US Manufacture Medical Device View Details
3013886523 Integra LifeSciences Switzerland Sarl Le Locle Neuchatel, CH Manufacture Medical Device View Details
3014334038 Integra LifeSciences Production Corporation Mansfield, MA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US Develop Specifications But Do Not Manufacture At This Facility View Details
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR Repack or Relabel Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K071458 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.