Auxein Nailing System
by Auxein Medical Private Limited 2 variants
510(k) K192003
Auxein Nailing System is a Class II device made by Auxein Medical Private Limited, cleared under FDA 510(k) K192003 on 10 Jun 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192003 | Date10 Jun 2020 | StatusActive |
Official records
- FDA 510(k) database K192003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192003
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 130° Ga-mma Nail TI-1457L-09-360L | TI-1457L-09-360L | 08903993372647 | — | On the market |
| 130° Ga-mma Nail TI-1457L-09-380L | TI-1457L-09-380L | 08903993372654 | — | On the market |
| 130° Ga-mma Nail TI-1457L-11-360R | TI-1457L-11-360R | 08903993373484 | — | On the market |
| 130° Ga-mma Nail TI-1457L-12-340R | TI-1457L-12-340R | 08903993373538 | — | On the market |
| 130° Ga-mma Nail TI-1457L-13-360L | TI-1457L-13-360L | 08903993372920 | — | On the market |
| 130° Ga-mma Nail TI-1457L-13-440R | TI-1457L-13-440R | 08903993373651 | — | On the market |
| 130° Ga-mma Nail TI-1457S-09-240 | TI-1457S-09-240 | 08903993372111 | — | On the market |
| 130° Ga-mma Nail TI-1457S-13-220 | TI-1457S-13-220 | 08903993372258 | — | On the market |
| AJAX Nail TI-6085-01-050 | TI-6085-01-050 | 08903993396773 | — | On the market |
| AJAX Nail TI-6085L-09-320R | TI-6085L-09-320R | 08903993432150 | — | On the market |
| AJAX Nail TI-6085L-09-380L | TI-6085L-09-380L | 08903993419878 | — | On the market |
| AJAX Nail TI-6085L-10-280R | TI-6085L-10-280R | 08903993396575 | — | On the market |
| AJAX Nail TI-6085L-12-360L | TI-6085L-12-360L | 08903993406397 | — | On the market |
| AJAX Nail TI-6085L-9-280R | TI-6085L-9-280R | 08903993396483 | — | On the market |
| AJAX Nail TI-6085L-9-300R | TI-6085L-9-300R | 08903993396490 | — | On the market |
| AJAX Nail TI-6086L-11-400L | TI-6086L-11-400L | 08903993423554 | — | On the market |
| AJAX Nail TI-6086L-12-280L | TI-6086L-12-280L | 08903993423585 | — | On the market |
| AJAX Nail TI-6086L-12-280R | TI-6086L-12-280R | 08903993423943 | — | On the market |
| AJAX Nail TI-6086L-9-340R | TI-6086L-9-340R | 08903993423707 | — | On the market |
| AJAX Nail TI-6086S-10-170 | TI-6086S-10-170 | 08903993423219 | — | On the market |
| Expert Femoral Nail TI-1458-4.8-064 | TI-1458-4.8-064 | 08903993392836 | — | On the market |
| Expert Femoral Nail TI-1458-4.8-080 | TI-1458-4.8-080 | 08903993408766 | — | On the market |
| Expert Femoral Nail TI-1458-4.8-082 | TI-1458-4.8-082 | 08903993415238 | — | On the market |
| Expert Femoral Nail TI-1459-075 | TI-1459-075 | 08903993366684 | — | On the market |
| Expert Femoral Nail TI-1459-10-360R | TI-1459-10-360R | 08903993366271 | — | On the market |
| Expert Femoral Nail TI-1459-110 | TI-1459-110 | 08903993366752 | — | On the market |
| Expert Femoral Nail TI-1459-12-420R | TI-1459-12-420R | 08903993376577 | — | On the market |
| Expert Femoral Nail TI-1459-12-440R | TI-1459-12-440R | 08903993376584 | — | On the market |
| Expert Femoral Nail TI-1459-13-440R | TI-1459-13-440R | 08903993376782 | — | On the market |
| Expert Femoral Nail TI-1459-130 | TI-1459-130 | 08903993376881 | — | On the market |
| Expert Tibia Nail TI-520-058-26 | TI-520-058-26 | 08903993392621 | — | On the market |
| Expert tibia nail TI-520-058-36 | TI-520-058-36 | 08903993359747 | — | On the market |
| Expert Tibia Nail TI-520-058-54 | TI-520-058-54 | 08903993359839 | — | On the market |
| Expert Tibia Nail TI-520-08-285 | TI-520-08-285 | 08903993374375 | — | On the market |
| Expert Tibia Nail TI-520-11-375 | TI-520-11-375 | 08903993374566 | — | On the market |
| Expert Tibia Nail TI-520-12-315 | TI-520-12-315 | 08903993374641 | — | On the market |
| Ga-mma Nail TI-600-038 | TI-600-038 | 08903993371350 | — | On the market |
| Ga-mma Nail TI-600-058 | TI-600-058 | 08903993363560 | — | On the market |
| Ga-mma Nail TI-600-080 | TI-600-080 | 08903993371503 | — | On the market |
| Ga-mma Nail TI-600-085 | TI-600-085 | 08903993371510 | — | On the market |
| Ga-mma Nail TI-600A-6.4-105 | TI-600A-6.4-105 | 08903993371756 | — | On the market |
| Ga-mma Nail TI-600A-6.4-120 | TI-600A-6.4-120 | 08903993363614 | — | On the market |
| Humeral Nail TI-6001.040 | TI-6001.040 | 08903993263181 | — | On the market |
| Humeral Nail TI-6001.050 | TI-6001.050 | 08903993263204 | — | On the market |
| Humeral Nail TI-6082-8.0-200 | TI-6082-8.0-200 | 08903993344293 | — | On the market |
| Retrograde Femoral Nail TI-1458-038 | TI-1458-038 | 08903993420386 | — | On the market |
| Retrograde Femoral Nail TI-1458-058 | TI-1458-058 | 08903993420485 | — | On the market |
| Retrograde Femoral Nail TI-1458-064 | TI-1458-064 | 08903993420515 | — | On the market |
| Retrograde Femoral Nail TI-1458-10-200 | TI-1458-10-200 | 08903993420089 | — | On the market |
| Retrograde Femoral Nail TI-1458-11-360 | TI-1458-11-360 | 08903993420188 | — | On the market |
Similar devices
Other devices filed under FDA product code JDS (Nail, Fixation, Bone).
- Centronail Titanium Universal Femoral Nailing System 1 99-T730425 by ORTHOFIX SRL
- Ankle Compression Nailing System 1 99-T770010 by ORTHOFIX SRL
- ODI TALON INTRAMEDULLARY HIP NAIL by Orthopaedic Designs, Inc.
- WIN Flexible Nail System by Biomet, Inc.
- SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM by Synthes (Usa)
- TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW by Smith & Nephew, Inc.
- CONNEXX LOCKING TIBIA NAIL by I.T.S. Implantat-Technologie-Systeme GmbH
- SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM by Synthes (Usa)
- MACMED PAEDIATRIC INTRAMEDULLARY NAIL by Innervision, Inc.
- HUMERAL LOCKING NAIL SYSTEM by Howmedica Corp.