510(k) K040762
- Device
- SYNTHES (USA) TIBIAL NAIL SYSTEM EX
- Applicant
- SYNTHES (USA)
- 510(k) number
- K040762
- Product code
- JDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-12
- Date received
- 2004-03-25
- Regulation
- 888.3030
- Classification name
- Nail, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERI L MUSGNUNG
- Address
- P.O. Box 1766 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3004638532
- 3015882686
- 3015183635
- 3003761012
- 3010220595
- 3005076207
- 9615021
- 3015869492
- 3035366890
- 3007420745
- 1825034
- 9613910
- 3015207155
- 3010009693
- 3043543260
- 3015440604
- 3010120104
- 3010041430
- 3017521423
- 3004358587
- 3006513362
- 3016237080
- 1722511
- 1058584
- 3016759112
- 9616944
- 3038503932
- 2183449
- 1043653
- 1833920
- 3010057495
- 3003525643
- 3013176080
- 3008868758
- 3009217531
- 3014527928
- 3015542154
- 9611390
- 3014170143
- 3014976005
- 3025603301
- 2031009
- 1526534
- 3019767615
- 3017528621
- 1835251
- 3010049501
- 3015869121
- 3015946784
- 2249615
- 3008791302
- 3006846753
- 1720929
- 1450662
- 3030412764
- 3007766601
- 3009417901
- 3006783837
- 9611813
- 3010363503
- 1828288
- 3015877656
- 3034676720
- 1020279
- 8043792
- 3021008900
- 3008534770
- 3009973505
- 3030714745
- 3002808145
- 3015869493
- 3014279513
- 3006017180
- 3002907620
- 3009882675
- 1834331
- 3009959868
- 3005497913
- 3009381600
- 3016438694
Source Documents#
Other 510(k) Records For Product Code JDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025-06-12 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | 2024-09-20 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | 2024-08-22 |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | 2024-02-20 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023-06-14 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | Synthes (USA) Products, LLC | 2020-09-03 |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020-06-10 |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | 2020-02-20 |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | 2015-04-08 |
| K123948 | CHINA NAILS AND ACCESSORIES | Smith & Nephew, Inc. | 2013-03-14 |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Synthes (Usa) | 2011-12-05 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | 2007-09-27 |
| K062872 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | Synthes (Usa) | 2007-03-13 |
| K061783 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2006-08-10 |
Legacy Summary#
summary
FDA Review#
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