Titanium Hartshill System
FDA 510(k) K991662 · Surgicraft , Ltd.
510(k) numberK991662
Submission
- Device name
- Titanium Hartshill System
- Applicant
- Surgicraft , Ltd.
Redditch, Worcs., GB - Received
- May 14, 1999
- Decision date
- November 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|
| K091207 | Surgicraft Lockdown Acromioclavicular (Ac) DeviceHTN · Traditional | 02/15/2011SE |
| K072370 | Surgicraft Surgical Mesh SystemFTL · Traditional | 07/24/2008SE |
| K080447 | Surgicraft Screw Fixation SystemMBI · Traditional | 06/13/2008SE |
| K073109 | Stalif TT Intervertebral Body Fusion SystemOVD · Abbreviated | 06/04/2008SE |
| K072415 | Stalif (TM) COVE · Abbreviated | 01/25/2008SE |
| K051027 | Stalif TTMQP · Traditional | 06/29/2005SE |
| K041617 | Stalif TTMQP · Traditional | 09/08/2004SE |
| K982719 | The Bone TieHTY · Traditional | 09/25/1998SE |
| K965221 | Ransford Cervical Fixation SystemKWP · Traditional | 08/07/1997SE |
Questions and answers
When was Titanium Hartshill System cleared by the FDA?
Titanium Hartshill System (K991662) received a 510(k) decision of Substantially Equivalent on November 8, 1999, 178 days after the submission was received.
What is the product code of K991662?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.