EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
FDA 510(k) clearance K862279 · decided 1986-07-25
Clearance details
- K-number
- K862279
- Device name
- EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
- Applicant
- Orthospec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-16
- Decision date
- 1986-07-25
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- KTW
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Spring Valley, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541) | Orthofix Srl | 2012-09-20 |
| 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.