510(k) K060249
- Device
- ULTRATINE FOREHEAD
- Applicant
- COAPT SYSTEMS, INC.
- 510(k) number
- K060249
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-12
- Date received
- 2006-01-31
- 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
- LINDA RUEDY
- Address
- 1820 Embarcadero Rd. Palo Alto CA US 94303 94303
FDA Registration Numbers#
- 3010667733
- 3014314623
- 2183946
- 1221934
- 3012478585
- 9610905
- 3006272282
- 3010440433
- 3025603301
- 3008812251
- 9611274
- 3013561205
- 3009996260
- 2245304
- 3014976005
- 3002719998
- 3015724777
- 3012711663
- 1047843
- 3011500362
- 1833506
- 3004983210
- 1226425
- 3009201148
- 3016669046
- 3012329552
- 3010673850
- 9611112
- 3002807295
- 1051526
- 3012491394
- 3024021261
- 3006498370
- 3004961578
- 3008236846
- 3016084569
- 2650143
- 3013365802
- 2649614
- 3022159082
- 3010502940
- 3022142628
- 9610612
- 3007913880
- 1060840
- 3011230048
- 1835831
- 3014554088
- 3025114181
- 1221051
- 3016112537
- 3002949614
- 3015167917
- 3015882686
- 1422572
- 3006639944
- 3011137372
- 3015231789
- 1000517406
- 3014128887
- 3035785605
- 3012755988
- 3021336182
- 3011127597
- 1064017
- 3015453963
- 1649390
- 3005076207
- 3031261833
- 1319660
- 3004358587
- 1643264
- 3018077525
- 3015259876
- 3006791286
- 3006179046
- 3014302784
- 3010047454
- 2028632
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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