510(k) K931155
- Device
- STAPLE, FIXATION BONE; SCREW FIXATION BONE
- Applicant
- ROSEBURG SA
- 510(k) number
- K931155
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-01
- Date received
- 1993-03-09
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ISABELLE FLOCCIA
- Address
- 1054 31st St., NW Suite 120 Canal Sq. Washington DC US 20007 20007
FDA Registration Numbers#
- 2133433
- 3004016606
- 3027827832
- 1724955
- 1061124
- 3010041430
- 3006846753
- 1057425
- 8031020
- 3009971621
- 3015539532
- 3006946279
- 3005536892
- 3012429289
- 8010665
- 3013820441
- 3015440604
- 1032347
- 3010531069
- 1835251
- 1834331
- 9611281
- 3004638532
- 1043534
- 3005827567
- 3015869121
- 2183946
- 3010536692
- 3010329663
- 3011530718
- 3015231789
- 3007766601
- 1835444
- 3004369035
- 3009189869
- 3023189283
- 1000461041
- 3005706667
- 3003249380
- 9610622
- 3009882462
- 3008102042
- 2244478
- 3030691054
- 3021948057
- 3016261131
- 3006179046
- 2183650
- 1424434
- 3002907620
- 3004358587
- 3012883081
- 3003755939
- 3034676720
- 3008668801
- 3009217531
- 1018470
- 3003935342
- 1219655
- 3004976965
- 3010287665
- 3015219237
- 3034532468
- 3017980266
- 2242056
- 3013540005
- 1833920
- 3005562917
- 3009153862
- 2090040
- 9680825
- 3014937101
- 3009513193
- 3013561205
- 3005004799
- 3033509898
- 3010606097
- 3009141957
- 3002806470
- 3023808054
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
Legacy Summary#
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FDA Review#
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