SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
FDA 510(k) clearance K963618 · decided 1996-11-12
Clearance details
- K-number
- K963618
- Device name
- SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1996-09-10
- Decision date
- 1996-11-12
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LXT
- 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 |
|---|---|---|
| Para-Fix External Fixation System (K230067) | New Paradigm Biomedical | 2023-09-22 |
| POLARUS CONNECT (K131636) | Acumed, LLC | 2013-10-10 |
| DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (K132704) | Biomet | 2013-10-09 |
| DISTAL VOLAR RADIUS PLATING SYSTEMS (K112345) | Medos International SARL | 2011-10-31 |
| STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S (K090374) | DePuy Orthopaedics, Inc. | 2009-03-11 |
| SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (K073135) | Synthes (Usa) | 2008-01-29 |
| SYNTHES (USA) ELBOW HINGE FIXATOR (K063832) | Synthes (Usa) | 2007-03-07 |
| MULTIDIRECTIONAL THREADED PEG (K060864) | Hand Innovations, LLC | 2006-04-28 |
| PTA (PROGRESSIVE TIBIAL ALIGNMENT) (K060403) | Meridian Medical | 2006-03-28 |
| SHOULDER FIXATION SYSTEM (K060290) | Hand Innovations, LLC | 2006-02-27 |
| WRIST FUSION PLATE (K052754) | Dvo Extremity Solutions, LLC | 2005-10-27 |
| MODIFICATION TO SHOULDER FIXATION SYSTEM (K051728) | Hand Innovations, LLC | 2005-07-20 |
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 |