BANDAGE SPREADER BLOCK
FDA 510(k) clearance K780227 · decided 1978-03-15
Clearance details
- K-number
- K780227
- Device name
- BANDAGE SPREADER BLOCK
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-09
- Decision date
- 1978-03-15
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- ILZ
- Device class
- 1
- Regulation number
- 890.5925
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biomet
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLEXION DISTRATION SUPPORT (K921711) | Altoona Medical Supply | 1992-07-13 |
| VIBRA-TRAC TRACTION TABLE (K895382) | Vibra-Trac Industries | 1989-10-16 |
| AMX-110, AMX-II AND AMX-III (K884340) | Dyna-Med | 1989-01-24 |
| VECTOR BAR SUSPENSION/TRACTION UNIT (K852398) | Powlan Manufacturing Co. | 1985-08-12 |
| TRACTION ACCESSORIES (K844490) | Jerome Medical | 1985-02-21 |
| SAUNDERS #7080 CERVICAL TRACTION SYS (K831135) | Chattanooga Group, Inc. | 1983-06-24 |
| HEAD HALTER (K830245) | Warm & Form, Orthopedic Materials | 1983-03-09 |
| PELVIC TRACTION BELT (K823659) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| PELVIC TRACTION BELT (K823166) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BOGER AUTO-TRACTION DEVICE (K820663) | D.C. Medical Device, Inc. | 1982-05-03 |
| CERVI-TRAC (K791808) | Dr. K.G. Rude | 1979-10-01 |
| TRACTION BELT, PELVIC (K780234) | Biomet, Inc. | 1978-02-23 |
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 |