510(k) K050041
- Device
- SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K050041
- Product code
- JDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-25
- Date received
- 2005-01-07
- Regulation
- 888.3010
- Classification name
- Cerclage, Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA M BOYLE
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3010331645
- 1032347
- 3015806723
- 1828464
- 1526534
- 1818910
- 3015399803
- 1424263
- 1720929
- 3006128100
- 3015974593
- 8010257
- 3003477135
- 3009973336
- 2032093
- 1833986
- 3015440604
- 2249615
- 3004635447
- 9616680
- 1220246
- 3033509898
- 1822565
- 3006946276
- 2027148
- 1825034
- 3008114965
- 3010155648
- 3004893332
- 9610726
- 1834379
- 3014262693
- 3016851379
- 3035366890
- 2028632
- 1220477
- 3008793310
- 3008556682
- 3012447612
- 3017528621
- 3011230048
- 3015231789
- 3025141
- 3015542154
- 3008812251
- 3014004349
- 3021008900
- 1423662
- 1824199
- 3038503932
- 3013011598
- 3010163695
- 9613369
- 1064858
- 3010363503
- 1450662
- 1824313
- 3006801265
- 3011295718
- 1828288
- 3043620689
- 3006395932
- 3002907620
- 3002807315
- 3016050940
- 3007366790
- 3006017180
- 3004142400
- 9610905
- 3010041499
- 3009882675
- 3010097171
- 8031020
- 3010191069
- 3008744062
- 9616062
- 3027404764
- 3004153896
- 1030489
- 3010173425
Source Documents#
Other 510(k) Records For Product Code JDQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | 2025-02-20 |
| K232733 | Mbrace Cable | Medacta International S.A. | 2024-05-03 |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | 2024-01-30 |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023-08-24 |
| K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023-08-04 |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | 2023-07-26 |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022-10-19 |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022-01-19 |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 |
| K193479 | Sternal Cable System | A & E Medical Corporation | 2020-03-23 |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018-10-12 |
Legacy Summary#
summary
FDA Review#
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