510(k) K780226
- Device
- Spreader Bars
- Applicant
- BIOMET, INC.
- 510(k) number
- K780226
- Product code
- ILZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-02-17
- Date received
- 1978-02-09
- Regulation
- 890.5925
- Classification name
- Accessories, Traction
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013473968
- 3004605321
- 3006297206
- 3012316249
- 3008956940
- 3017264244
- 1511629
- 3017504598
- 2011171
- 3006891384
- 3042148166
- 8040278
- 3016796158
- 3006227741
- 1642835
- 3007207474
- 3011706862
- 3035708926
- 1000328618
- 1422598
- 2029275
- 3010452421
- 3007278668
- 1043214
- 3008008970
- 3012660022
- 2435707
- 1824206
- 9680668
- 1054236
- 2027062
- 9617759
- 3013591868
- 9616877
- 1822565
- 1523547
- 3011559089
- 3016964847
- 9616086
- 3008808049
- 3005273623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921711 | FLEXION DISTRATION SUPPORT | Altoona Medical Supply | 1992-07-13 |
| K895382 | VIBRA-TRAC TRACTION TABLE | Vibra-Trac Industries | 1989-10-16 |
| K884340 | AMX-110, AMX-II AND AMX-III | Dyna-Med | 1989-01-24 |
| K852398 | VECTOR BAR SUSPENSION/TRACTION UNIT | Powlan Manufacturing Co. | 1985-08-12 |
| K844490 | TRACTION ACCESSORIES | Jerome Medical | 1985-02-21 |
| K831135 | SAUNDERS #7080 CERVICAL TRACTION SYS | Chattanooga Group, Inc. | 1983-06-24 |
| K830245 | HEAD HALTER | Warm & Form, Orthopedic Materials | 1983-03-09 |
| K823659 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823166 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K820663 | BOGER AUTO-TRACTION DEVICE | D.C. Medical Device, Inc. | 1982-05-03 |
| K791808 | CERVI-TRAC | Dr. K.G. Rude | 1979-10-01 |
| K780227 | BANDAGE SPREADER BLOCK | Biomet, Inc. | 1978-03-15 |
| K780234 | TRACTION BELT, PELVIC | Biomet, Inc. | 1978-02-23 |
| K770607 | TRACTION HARNESS | Will Ross Co. | 1977-04-08 |