510(k) K031155
- Device
- OSTEOMED SUBTALAR IMPLANT SYSTEM
- Applicant
- OSTEOMED L.P.
- 510(k) number
- K031155
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-22
- Date received
- 2003-04-11
- 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
- DAWN T HOLDEMAN
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
FDA Registration Numbers#
- 3016778139
- 3038776593
- 3004142400
- 3016050940
- 3004983210
- 3011127597
- 3006395932
- 2242056
- 2020550
- 3015895045
- 3001239363
- 3032314868
- 3008868758
- 9611281
- 3015869121
- 3010509633
- 2936485
- 3014763043
- 9611813
- 1423662
- 3003541440
- 9613350
- 3042765769
- 3019455
- 3017980266
- 3009882675
- 3008749819
- 3005004799
- 3009996260
- 3009381600
- 3008559295
- 2244478
- 9680825
- 3015200759
- 3009504230
- 3012329552
- 3030655570
- 1000517406
- 3013055499
- 3014315669
- 3008668801
- 3027827832
- 8010944
- 3029933740
- 3010123172
- 2133433
- 3014273424
- 3011388423
- 2090040
- 3015877656
- 1032347
- 3010622588
- 3022520753
- 3010158639
- 3026576110
- 1036836
- 3014967149
- 3002806470
- 2650143
- 9710629
- 1018470
- 3016851379
- 1644408
- 3009826895
- 3031240334
- 3006563559
- 3014232239
- 9710312
- 3009973699
- 3042903229
- 2031917
- 3004049923
- 3023808054
- 3006946279
- 3023189283
- 3010041511
- 2183744
- 3010363503
- 3017435639
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 |
Legacy Summary#
summary
FDA Review#
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