510(k) K011168
- Device
- NEUROGEN NERVE GUIDE
- Applicant
- INTEGRA LIFESCIENCES CORP.
- 510(k) number
- K011168
- Product code
- JXI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-22
- Date received
- 2001-04-17
- Regulation
- 882.5275
- Classification name
- Cuff, Nerve
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH E O'GRADY
- Address
- 105 Morgan Ln. Plainsboro NJ US 08536 08536
FDA Registration Numbers#
- 3009756327
- 3012222873
- 2027062
- 2650143
- 3002808271
- 3027448274
- 2648988
- 3015380522
- 3003418325
- 9612125
- 3012669262
- 1121308
- 3022317591
- 3017860045
- 2030598
- 3000215346
- 9614559
- 3009493875
- 3032193320
- 3002807314
- 3025664014
- 3009039068
- 3024511918
- 1000393132
- 3005941719
- 2249852
- 3022140316
- 1319660
- 1319639
- 3011006318
- 3014015147
- 2245304
- 1835959
- 3019147058
Source Documents#
Other 510(k) Records For Product Code JXI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260245 | SILKBridge | KLISBio S.r.l. | 2026-04-09 |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | 2026-01-17 |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025-07-22 |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | 2025-07-17 |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. | 2025-04-02 |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | 2025-04-02 |
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 |
| K233533 | NerveTape | Biocircuit Technologies, Inc. | 2024-02-12 |
| K230794 | Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., | 2024-01-29 |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023-11-02 |
| K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | 2023-10-12 |
| K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | 2023-04-07 |
| K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022-07-15 |
| K202234 | NervAlign Nerve Cuff | Renerve, Ltd. | 2022-02-10 |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020-09-14 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases