510(k) K970912
- Device
- LEIBINGER SELF-DRILLING SCREW
- Applicant
- HOWMEDICA LEIBINGER, INC.
- 510(k) number
- K970912
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-01
- Date received
- 1997-03-12
- 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
- KRISTYN WASKI
- Address
- 14540 Beltwood Pkwy. E. Dallas TX US 75244 75244
FDA Registration Numbers#
- 3010097171
- 3014302784
- 3001239363
- 9617083
- 1424263
- 3005004799
- 3011530718
- 3015869492
- 3010560653
- 3023265483
- 9613910
- 3010440433
- 3007143290
- 3022518322
- 3017521423
- 3023808054
- 3010178296
- 2431166
- 9614209
- 2090040
- 3004358587
- 3026311512
- 3006513362
- 3004016606
- 3010118938
- 3016247852
- 3016261131
- 3006563559
- 3012130008
- 3008102042
- 2532027
- 3009144915
- 3002807295
- 3012086398
- 3007319107
- 3010287665
- 3007113169
- 1833920
- 3010057495
- 1319660
- 1835296
- 3017210488
- 3013014058
- 3016660811
- 1649390
- 3011187779
- 3010407203
- 3017196117
- 3010041511
- 3013176080
- 3009217531
- 3015542154
- 3007700286
- 3015531529
- 3026586698
- 3006498370
- 3023272531
- 3027339877
- 3014170143
- 1835572
- 3016669046
- 1319639
- 2246552
- 1000517406
- 3008824097
- 2031009
- 3008599979
- 3008837339
- 3009732568
- 3012103114
- 3015410662
- 3009504230
- 3008729892
- 1833986
- 3016112537
- 3009888740
- 1036836
- 3010049501
- 3005596372
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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