Isola(Tm) Spine System Top Entry Hook
FDA 510(k) K905184 · Acromed Corp.
510(k) numberK905184
Submission
- Device name
- Isola(Tm) Spine System Top Entry Hook
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- November 19, 1990
- Decision date
- February 15, 1991
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K980485 | Isola Spinal SystemMNI · Traditional | 10/21/1998SE |
| K981714 | Timx Low Back System Titanium MX Rod Based Low Back SystemMNH · Traditional | 06/30/1998SE |
| K981113 | Pediatric PRCMNH · Traditional | 05/29/1998SE |
| K981274 | Acromed Timx Plate Based Low Back SystemMNH · Special | 04/29/1998SE |
| K980228 | University Plate Anterior SystemKWQ · Traditional | 04/14/1998SN |
| K974757 | Kaneda Anterior Scoliosis System KassKWQ · Traditional | 03/05/1998SN |
| K972718 | M-2 Anterior Plate SystemKWQ · Traditional | 10/01/1997SN |
| K971248 | Kaneda SR Anterior Spinal SystemKWQ · Traditional | 06/11/1997SN |
| K970955 | Acromed Anterior Cervical Stabilization SystemKWQ · Traditional | 06/11/1997SN |
| K970950 | Easy RodMNH · Traditional | 06/03/1997SE |
Questions and answers
When was Isola(Tm) Spine System Top Entry Hook cleared by the FDA?
Isola(Tm) Spine System Top Entry Hook (K905184) received a 510(k) decision of Substantially Equivalent for Some Indications on February 15, 1991, 88 days after the submission was received.
What is the product code of K905184?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.