Harrington Spinal Elevator
FDA 510(k) K781449 · Orthopedic Equipment Co., Inc.
510(k) numberK781449
Submission
- Device name
- Harrington Spinal Elevator
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- August 23, 1978
- Decision date
- September 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEG – Elevator, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891899 | Elevators, Various TypesGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891894 | Elevators-Cottle,Mckenty,Goldman,Joseph,ConverseGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K890365 | Septum ElevatorGEG · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890253 | Surgical ElevatorGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890230 | Ligature NeedlesGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K872491 | 1.1 Twist Drills and 1.2 Cortical DrillsGEG · Traditional | Micro-Aire Surgical Instruments, Inc. | 07/16/1987SE |
| K870781 | Acromed Wallie-Heinig Disector/ElevatorsGEG · Traditional | Buckman Co., Inc. | 03/09/1987SE |
| K870591 | Elevator, Cobb SpinalGEG · Traditional | Military Engineering, Inc. | 02/26/1987SE |
| K870126 | Femur WrenchGEG · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
More from Cedar Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
| K841189 | Oec/Rezaian Spinal FixatorKWQ · Traditional | 05/16/1984SE |
| K800530 | Schlein Tri-Surface AnkleHSN · Traditional | 04/02/1980SE |
| K781445 | SpreaderGAD · Traditional | 09/27/1979SE |
| K790247 | Tourniquet Test Gage · Traditional | 02/26/1979SE |
| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
| K781447 | Threaded Rod ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Harrington Spinal Elevator cleared by the FDA?
Harrington Spinal Elevator (K781449) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 35 days after the submission was received.
What is the product code of K781449?
The FDA product code is GEG – Elevator, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.