COMPRESSION HIP SCREW SYSTEM
FDA 510(k) clearance K781762 · decided 1978-12-20
Clearance details
- K-number
- K781762
- Device name
- COMPRESSION HIP SCREW SYSTEM
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-16
- Decision date
- 1978-12-20
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- KTW
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| AOS PROXIMAL HUMERAL PLATE (K080590) | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 |
| SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109) | Synthes (Usa) | 2008-03-20 |
| ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920) | Orthofix Srl | 2006-11-13 |
| LEFORTE SYSTEM BONE PLATE (K023360) | Jeil Medical Corporation | 2002-10-25 |
| REPROCESSED EBI EXTERNAL FIXATION DEVICES (K012645) | Alliance Medical Corp. | 2002-06-24 |
| REPROCESSED EXTERNAL FIXATION DEVICE (K012634) | Alliance Medical, Inc. | 2002-06-24 |
| SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815) | Synthes (Usa) | 2001-09-06 |
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 |