HARRINGTON SPINAL ELEVATOR
FDA 510(k) clearance K781449 · decided 1978-09-27
Clearance details
- K-number
- K781449
- Device name
- HARRINGTON SPINAL ELEVATOR
- Applicant
- Orthopedic Equipment Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-23
- Decision date
- 1978-09-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- GEG
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orthopedic Equipment Co.
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 |
|---|---|---|
| ELEVATORS, VARIOUS TYPES (K891899) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (K891894) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| SEPTUM ELEVATOR (K890365) | Kinetic Medical Products | 1989-02-03 |
| SURGICAL ELEVATOR (K890253) | Kinetic Medical Products | 1989-01-27 |
| LIGATURE NEEDLES (K890230) | Kinetic Medical Products | 1989-01-27 |
| 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (K872491) | Micro-Aire Surgical Instruments, Inc. | 1987-07-16 |
| ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (K870781) | Buckman Co., Inc. | 1987-03-09 |
| ELEVATOR, COBB SPINAL (K870591) | Military Engineering, Inc. | 1987-02-26 |
| FEMUR WRENCH (K870126) | Orthopedic Systems, Inc. | 1987-02-03 |
| RAYLOR(TM) PERIOSTEAL ELEVATORS (K864421) | Cedar Surgical, Inc. | 1986-11-26 |
| H.R. JAKOBI SURG. INSTRUMENTS 40/41 (K834176) | Imm Enterprises , Ltd. | 1984-01-27 |
Recalls involving this device
No recalls on record reference this clearance.