510(k) K063070
- Device
- APERFIX TIBIAL IMPLANT WITH INSERTER
- Applicant
- CAYENNE MEDICAL, INC.
- 510(k) number
- K063070
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-14
- Date received
- 2006-10-06
- 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
- Floyd Larson
- Address
- 11234 El Camino Real Suite 200 San Diego CA US 92130 92130
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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