510(k) K121541
- Device
- JAZZ SYSTEM
- Applicant
- IMPLANET S.A.
- 510(k) number
- K121541
- Product code
- JDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-13
- Date received
- 2012-05-24
- 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
- JANICE M HOGAN
- Address
- 1835 Market St., 29th Floor Philedelphia PA US 19103 19103
FDA Registration Numbers#
- 3014262693
- 9616680
- 2027148
- 3006128100
- 2029275
- 9610612
- 3010041499
- 3013756169
- 1423662
- 3021008900
- 3004986960
- 3015974593
- 3016851379
- 3019269298
- 3033509898
- 3010400367
- 3008110533
- 3014004349
- 1047843
- 3002907620
- 3009971621
- 3018094310
- 3012883081
- 3009973505
- 3010331645
- 1833824
- 1043653
- 1221053
- 2249697
- 3008868758
- 3006395932
- 2028632
- 3043620689
- 3010097171
- 1064858
- 3008951116
- 3010363503
- 1032347
- 3008556682
- 1824199
- 8043792
- 3014680795
- 1526439
- 1818910
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3015231789
- 3003761012
- 3008812560
- 2242056
- 3009882675
- 3015869493
- 3025141
- 3017528621
- 3005180920
- 3000270450
- 3009417901
- 3015440604
- 1020279
- 1825034
- 2032093
- 2183946
- 2953359
- 1226544
- 1643817
- 1833986
- 3011230048
- 3013055499
- 1828288
- 1822565
- 3016438694
- 3021226419
- 1526534
- 3025603301
- 1220246
- 3002807315
- 3015876273
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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