510(k) K230946
- Device
- Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
- Applicant
- Trax Surgical
- 510(k) number
- K230946
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-15
- Date received
- 2023-04-04
- 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
- Steven Tallarida
- Address
- 75 Mill St. Stoughton MA US 02072 02072
FDA Registration Numbers#
- 2031009
- 3014937101
- 3014279513
- 3004499989
- 3015806723
- 9614438
- 1526534
- 2090040
- 3010197224
- 3007109793
- 2320767
- 9681465
- 9614209
- 3010120339
- 3005641619
- 3007583504
- 2183449
- 9611390
- 3002719998
- 3010202439
- 3006849754
- 3008696586
- 3004635447
- 2532027
- 3015877656
- 9611112
- 3008114965
- 3010155648
- 8031010
- 9610726
- 9610617
- 3009337401
- 3014104093
- 3006001176
- 3014262693
- 3016851379
- 3010560653
- 3012429289
- 3005827567
- 3011943495
- 3009513193
- 1054811
- 1038671
- 3015724777
- 3008793310
- 3017528621
- 3007113169
- 3017196117
- 9680825
- 3011656326
- 9617297
- 2530808
- 3025141
- 3032588003
- 3021010222
- 9610622
- 1226146
- 3010329663
- 3030926959
- 3021008900
- 3016669046
- 3000327445
- 3009532798
- 3011301313
- 3038503932
- 3013011598
- 3006742481
- 9613369
- 3010303097
- 9613910
- 3029933740
- 1828288
- 9613350
- 3012966183
- 3014207283
- 3002907620
- 1064017
- 3006513362
- 3009882462
- 3009144915
Source Documents#
Other 510(k) Records For Product Code HWC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 |