CERVICAL SUPPORT
FDA 510(k) clearance K811297 · decided 1981-05-27
Clearance details
- K-number
- K811297
- Device name
- CERVICAL SUPPORT
- Applicant
- Orthomedics
- Decision
- Substantially Equivalent
- Date received
- 1981-05-11
- Decision date
- 1981-05-27
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- IQF
- Device class
- 1
- Regulation number
- 890.3490
- 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 |
|---|---|---|
| JASON CERVICAL ORTHOSIS (K832741) | Orthomedics | 1983-09-20 |
| ZEE EXTRICATION DEVICE (K812342) | Zee Medical Products Co., Inc. | 1981-09-21 |
| SCOLIOSIS ORTHOTIC SYSTEM (K810555) | Orthomedics | 1981-03-13 |
| POPE AMBULATORY HALO VEST (K791350) | Hospital Products Co. | 1979-08-03 |
| KENDRICK EXTRICATION DEVICE (K781761) | Medi-Ked, Inc. | 1978-10-27 |
| SPINE BOARD (K780489) | Marullo, Baldwin, Frieden, Gatewood, | 1978-04-12 |
Recalls involving this device
No recalls on record reference this clearance.