REBOUND THERAPEUTICS, CORPORATION

FDA Device Registration & Listing · Irvine, CA, US · Registration 3013505638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013505638
FEI Number
3013505638
Entity Name
REBOUND THERAPEUTICS, CORPORATION
City/State/Country
Irvine, CA, US
Establishment Address
13900 Alton Parkway, Suite 120, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

AURORA Surgiscope System Aurora Evacuator Aurora Surgiscope System ASX9/100 ASX9/130 Aurora Surgiscope System ASX9/70 ICB/ASX15 AURORA Evacuator + Coag

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2025-04-14
GWG Endoscope, Neurological Neurology Class 2 882.1480 2025-04-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-10-08
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2019-12-17
GWG Endoscope, Neurological Neurology Class 2 882.1480 2019-12-17
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2023-11-01
GWG Endoscope, Neurological Neurology Class 2 882.1480 2023-11-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
3004608878 INTEGRA LIFESCIENCES CORPORATION CINCINNATI, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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9710524 ULTIMATE MEDICAL PRODUCTS LTD. SHARJAH Ash Shariqah, AE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013505638. Last updated year: 2026. Please use registration number 3013505638 when referencing this establishment in official correspondence.
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