510(k) K161616
- Device
- DePuy Synthes 4.0 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4.0 Mm Cannulated Screws, DePuy Synthes 4.5 Mm Cannulated Screws, DePuy Synthes 6.5 Mm Cannulated Screws, DePuy Synthes 7.0 Mm And 7.3 Mm
- Applicant
- Synthes USA Products, LLC
- 510(k) number
- K161616
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-16
- Date received
- 2016-06-13
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nina Rudolph
- Address
- 1301 Goshen Pkwy. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3003935342
- 3013767421
- 3015974593
- 3012755988
- 3010622588
- 3007740680
- 3012131184
- 3009201148
- 3007143290
- 1722511
- 3010606097
- 3009882675
- 3004993707
- 1319639
- 1835572
- 3015410662
- 3011170410
- 9610622
- 3004549189
- 3011683674
- 3009141957
- 1043534
- 3014004349
- 3007113169
- 3011530718
- 3010068573
- 1221051
- 3017980266
- 3014967149
- 3015946784
- 8043862
- 1051526
- 3016678045
- 3009812190
- 3042903229
- 3011127597
- 3006017180
- 9610617
- 3012818475
- 3030412764
- 3030514683
- 3023265483
- 3030183061
- 3007993775
- 3018077525
- 3011354099
- 3013700547
- 9614209
- 3030655570
- 3013176080
- 3015877656
- 3015718210
- 3015151147
- 1061124
- 3022777867
- 3035373797
- 3015724777
- 3006460162
- 3004431266
- 3013055499
- 3010155648
- 3014763043
- 3029894043
- 2183449
- 3005536892
- 2649614
- 3022928161
- 3013011598
- 3007441485
- 3007319107
- 9613350
- 1531050
- 3017196117
- 3010041430
- 3015831087
- 3021948057
- 3006395932
- 3021632375
- 3006563559
- 8044172
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026-09-23 |
| K254280 | F.A.S.T Screw | Steps Ortho | 2026-09-21 |
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
Legacy Summary#
summary
FDA Review#
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