NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
FDA 510(k) clearance K032115 · decided 2003-10-10
Clearance details
- K-number
- K032115
- Device name
- NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
- Applicant
- Polyganics B.V.,
- Decision
- Substantially Equivalent
- Date received
- 2003-07-09
- Decision date
- 2003-10-10
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- JXI
- Device class
- 2
- Regulation number
- 882.5275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Groningen, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| SILKBridge (K260245) | KLISBio S.r.l. | 2026-04-09 |
| NeuroSpan Bridge (K253363) | Auxilium Biotechnologies, Inc. | 2026-01-17 |
| VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (K251505) | Alafair Biosciences | 2025-07-22 |
| VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (K251175) | Alafair Biosciences | 2025-07-17 |
| 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) (K243889) | Orthocell, Ltd. | 2025-04-02 |
| Nerve Wrap (07-DW-001-TAB) (K242113) | Biocircuit Technologies, Inc. | 2025-04-02 |
| Mochida Nerve Cuff (K233322) | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 |
| NerveTape (K233533) | Biocircuit Technologies, Inc. | 2024-02-12 |
| Rebuilder Nerve Guidance Conduit (K230794) | Celestray Biotech Company, LLC., | 2024-01-29 |
| VersaWrap Nerve Protector (K232029) | Alafair Biosciences, Inc. | 2023-11-02 |
| 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) (K231708) | Axogen Corporation | 2023-10-12 |
| 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) (K223640) | Axogen Corporation | 2023-04-07 |
Recalls involving this device
No recalls on record reference this clearance.