VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
FDA 510(k) clearance K864633 · decided 1986-12-18
Clearance details
- K-number
- K864633
- Device name
- VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-25
- Decision date
- 1986-12-18
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| 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 |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |