3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
FDA 510(k) clearance K992837 · decided 1999-10-25
Clearance details
- K-number
- K992837
- Device name
- 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1999-08-23
- Decision date
- 1999-10-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- KTW
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, 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 |
|---|---|---|
| PK High Tibial Osteotomy Correction System (K182285) | Paonan Biotech Co., Ltd. | 2019-06-20 |
| AOS Anterolateral Proximal Humeral Plate (K171606) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 |
| Phantom Small Bone Intramedullary Nail System (K170693) | Paragon 28, Inc. | 2017-06-19 |
| AOS Anterolateral Proximal Humeral Plate (K160409) | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |