510(k) K800894
- Device
- DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
- Applicant
- DEPUY, INC.
- 510(k) number
- K800894
- Product code
- JDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-02
- Date received
- 1980-04-18
- Regulation
- 888.3030
- Classification name
- Nail, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008812251
- 3010041993
- 3007923096
- 3010386387
- 3043543260
- 3007740680
- 3010120135
- 3004748528
- 1721676
- 3005581234
- 1722511
- 3011274144
- 1020279
- 3005061536
- 3009760038
- 1219655
- 1423662
- 3008395353
- 3010097171
- 3011170410
- 1835251
- 3011683674
- 3003541440
- 2246552
- 3006946279
- 3020155054
- 3012130008
- 3023852420
- 1833920
- 3010163695
- 3014302784
- 3001278222
- 3002807310
- 3010132111
- 3003595343
- 1424263
- 3015398319
- 2244478
- 3010220595
- 3010041693
- 3005180920
- 3005360851
- 3005551626
- 3006017180
- 2134285
- 3008102042
- 3004153896
- 3007200272
- 3002807090
- 3002807314
- 3009173317
- 1057425
- 3030412764
- 1531174
- 2011171
- 3018094310
- 3005323511
- 9614209
- 3042508254
- 1643817
- 9616671
- 3003761012
- 3002806603
- 3002808022
- 1058584
- 3008281151
- 3003998208
- 3015259876
- 2245304
- 3013176080
- 3009973336
- 3020162561
- 9681465
- 3006801265
- 3002807315
- 3010288357
- 3009973505
- 3011015572
- 3009882462
- 1833506
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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