510(k) K980944
- Device
- SYNTHES SCHUHLI IMPLANT SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K980944
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-27
- Date received
- 1998-03-12
- Regulation
- 888.3030
- Classification name
- Washer, Bolt Nut
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANGELA J SILVESTRI
- Address
- 1690 Russell Rd. Post Office Box 1766 Paoli PA US 19301 19301
FDA Registration Numbers#
- 1835251
- 1051526
- 3007829657
- 2183946
- 3003525643
- 3007663067
- 3016084569
- 3013055499
- 3016851379
- 1649390
- 3021008900
- 3009756153
- 3010622588
- 3004638532
- 3014763043
- 3005497913
- 1450662
- 3007441485
- 3015882686
- 2030624
- 3010400367
- 3008114965
- 3032412536
- 3010041499
- 3006801265
- 3001239363
- 3014967969
- 3009158523
- 3010646402
- 3013011598
- 3008868758
- 1061927
- 3010863450
- 1032347
- 3030514683
- 3008812560
- 2953359
- 3031261833
- 1833824
- 3003604053
- 3042765769
- 3020704423
- 2133433
- 3009971621
- 2090040
- 3006272282
- 1526439
- 1226146
- 3010273872
- 3013176080
- 3031800723
- 3008396464
- 1724955
- 1054811
- 3009996260
- 3015974593
- 1935627
- 3010120339
- 3014262693
- 3011580264
- 3038503932
- 8043792
- 3015539532
- 3011061237
- 3005290844
- 1221934
- 1064129
- 3020899789
- 9613350
- 3043620689
- 3022142628
- 1818910
- 3014302784
- 3021226419
- 3002807315
- 3017980495
- 3008951116
- 1424263
- 1048735
- 1720929
Source Documents#
Other 510(k) Records For Product Code HTN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253115 | LARS ACJ | Movmedix S.A.S. | 2026-06-10 |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026-03-27 |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 2025-12-22 |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| K251134 | RipCord | TriMed, Inc. | 2025-07-11 |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | 2025-01-23 |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-11-27 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-08-01 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 |
| K233531 | OIC FLEX-FIX™ System | Orthopaedic Implant Company | 2024-02-02 |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | 2023-12-18 |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023-10-06 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022-08-22 |
Legacy Summary#
summary
FDA Review#
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