EXACTECH BONE SCREW
FDA 510(k) clearance K896601 · decided 1989-12-06
Clearance details
- K-number
- K896601
- Device name
- EXACTECH BONE SCREW
- Applicant
- Exactech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-21
- Decision date
- 1989-12-06
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GFS - Sterile Screws and Top Hat (K253858) | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| Lapidus Screw Kit (K262075) | Relja Innovations, LLC | 2026-07-22 |
| Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (K260809) | Arthrex, Inc. | 2026-06-25 |
| VEOFIX Snap Off Screw (K253108) | Steps Ortho | 2026-06-05 |
| CoLink® & CoLag® Non-Sterile Screws (K261154) | In2Bones USA, LLC | 2026-05-30 |
| TriMed Compression Screws (K261241) | TriMed, Inc. | 2026-05-14 |
| Arthrex Beaming System (K254215) | Arthrex, Inc. | 2026-05-08 |
| OSSIOfiber® Threaded Trimmable Fixation Nail (K254077) | OSSIO , Ltd. | 2026-05-01 |
| TITAN Nail; APTUS K-Wire System (K260934) | Medartis AG | 2026-04-17 |
| CoAptix S System (K252699) | University of Utah, Department of Orthopaedics | 2026-04-10 |
| Tyber Medical Trauma Screw (K253042) | Tyber Medical, LLC | 2026-04-03 |
| DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110) | MedShape, Inc. | 2026-03-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021) | Exactech, Inc. | 2017-04-03 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020) | Exactech, Inc. | 2016-09-28 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019) | Exactech, Inc. | 2016-07-21 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017) | Exactech, Inc. | 2016-04-26 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018) | Exactech, Inc. | 2015-12-30 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016) | Exactech, Inc. | 2014-06-18 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015) | Exactech, Inc. | 2013-02-07 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014) | Exactech, Inc. | 2012-12-05 |