Blackstone Medical, Inc., Pillar Spacer System
FDA 510(k) K081177 · Blackstone Medical, Inc.
510(k) numberK081177
Submission
- Device name
- Blackstone Medical, Inc., Pillar Spacer System
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- April 25, 2008
- Decision date
- July 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K081684 | Blackstone Pedicle Screw SystemNKB · Traditional | 09/15/2008SE |
| K082235 | Blackstone Pillar XL PEEK SpacersMAX · Special | 09/04/2008SE |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceOVD · Special | 08/28/2008SE |
| K080407 | Blackstone SFS Parallel Rod ConnectorsMNI · Special | 03/13/2008SE |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemKWP · Special | 03/13/2008SE |
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Questions and answers
When was Blackstone Medical, Inc., Pillar Spacer System cleared by the FDA?
Blackstone Medical, Inc., Pillar Spacer System (K081177) received a 510(k) decision of Substantially Equivalent on July 23, 2008, 89 days after the submission was received.
What is the product code of K081177?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.