Elevator, Cobb Spinal
FDA 510(k) K870591 · Military Engineering, Inc.
510(k) numberK870591
Submission
- Device name
- Elevator, Cobb Spinal
- Applicant
- Military Engineering, Inc.
Plymouth, IN, US - Received
- February 10, 1987
- Decision date
- February 26, 1987
- 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 |
| K870126 | Femur WrenchGEG · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
| K834176 | H.R. Jakobi Surg. Instruments 40/41GEG · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874335 | Explorer-Dental ProberEKJ · Traditional | 12/29/1987SE |
| K873715 | Bone Pin Cutter 18HXZ · Traditional | 10/28/1987SE |
| K872842 | Pin, Hip, KnowlesHTY · Traditional | 08/07/1987SE |
| K872091 | Currettes, Alveolar (Molt and Miller)EMS · Traditional | 07/31/1987SE |
| K871834 | Drill, Hand, Bone, SmedbergDZJ · Traditional | 07/31/1987SE |
| K872738 | Cortical Bone ScrewsHWC · Traditional | 07/30/1987SE |
| K872609 | Curette Set, Antrum, CoakleyKAP · Traditional | 07/15/1987SE |
| K871818 | Spatula, Dental, CementEJB · Traditional | 07/02/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | 06/23/1987SE |
| K870590 | Curette, Periodontal, Columbia UniversityEMS · Traditional | 04/16/1987SE |
Questions and answers
When was Elevator, Cobb Spinal cleared by the FDA?
Elevator, Cobb Spinal (K870591) received a 510(k) decision of Substantially Equivalent on February 26, 1987, 16 days after the submission was received.
What is the product code of K870591?
The FDA product code is GEG – Elevator, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.