ORTHOSISES DEVICES
FDA 510(k) clearance K780225 · decided 1978-02-24
Clearance details
- K-number
- K780225
- Device name
- ORTHOSISES DEVICES
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-09
- Decision date
- 1978-02-24
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- IQI
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, 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 |
|---|---|---|
| Neurosplint (K143458) | Neurospectrum, LLC | 2015-08-13 |
| SENSOR WALK (K052771) | Otto Bock Healthcare LP | 2006-05-03 |
| SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) | Surgitech, Inc. | 2003-07-31 |
| ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391) | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| MCCONNELL SHOULDER BRACE (K910974) | Mcconnell Orthopedic | 1991-03-21 |
| GAIT-AID ORTHOPEDIC INSOLE (K874502) | Gait-Aid, Inc. | 1987-11-30 |
| ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542) | Fred Sammons, Inc. | 1983-06-24 |
| DROP FOOT BRACE (K831615) | Edward Dilauro, Jr. | 1983-06-15 |
| VARIOUS SUPPORTS AND SPLINTS (K823812) | Danek Medical, Inc. | 1983-01-14 |
| BRACE-UP ALL PURPOSE WRIST BAND (K823113) | Arco Matic, Inc. | 1982-11-16 |
| ROTATION BOOT (K823160) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BRACE-UP STOCKING KNEE BRACE (K823114) | Arco Matic, Inc. | 1982-11-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |