510(k) K781389
- Device
- BIOMET CONCENTRIC HEX SCREW
- Applicant
- BIOMET, INC.
- 510(k) number
- K781389
- Product code
- JDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-21
- Date received
- 1978-08-10
- Regulation
- 888.3030
- Classification name
- Device, Fixation, Proximal Femoral, Implant
- 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#
- 1000550978
- 3036756245
- 3038503932
- 1835251
- 3015207155
- 2029275
- 3009973336
- 3009959868
- 3014129047
- 3009887475
- 3006460162
- 2183449
- 3022142628
- 1828464
- 2249615
- 3005061536
- 3003761012
- 3008812560
- 3009826895
- 3006783837
- 1450662
- 3043543260
- 3021008900
- 3002807310
- 9680825
- 3008744062
- 3009417901
- 3015440604
- 1020279
- 9613369
- 3010120135
- 3003541440
- 3006017180
- 3004188066
- 1825034
- 3033509898
- 3004142400
- 3008791302
- 3013176080
- 1643264
- 3007993775
- 3011500362
- 3002907620
- 3009973505
- 3013055499
- 3035366890
- 1043653
- 2134947
- 3007366790
- 1221053
- 3016438694
- 3015399803
- 3008868758
- 1526534
- 3034676720
- 3011656326
- 3025603301
- 1833920
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JDO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023-04-18 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | Smith & Nephew, Inc. | 2022-09-29 |
| K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 |
| K193029 | CONQUEST FN | Smith & Nephew, Inc. | 2020-02-28 |
| K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018-02-07 |
| K172785 | CONQUEST FN | Smith & Nephew | 2017-12-22 |
| K152686 | CONQUEST FN | Smith & Nephew | 2016-03-17 |
| K140018 | TSP HIP FRACTURE PLATING SYSTEM | Biomet, Inc. | 2014-04-04 |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | 2008-08-15 |
| K080434 | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | Smith & Nephew, Inc. | 2008-04-10 |
| K983814 | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | Efratgo, Ltd. HI Tech Bio-Surgical | 1999-01-14 |
| K981757 | SYNTHES (USA) DHS HELIX SYSTEM | Synthes (Usa) | 1998-07-17 |
| K964259 | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION | Synthes (Usa) | 1997-01-09 |
| K962644 | VIGOR COMPRESSION HIP SCREW SYSTEM | Deutschland Surgical, Inc. | 1996-09-06 |
| K953607 | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) | Synthes (Usa) | 1996-03-08 |
Legacy Summary#
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FDA Review#
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