Blackstone SFS Parallel Rod Connectors
FDA 510(k) K080407 · Blackstone Medical, Inc.
510(k) numberK080407
Submission
- Device name
- Blackstone SFS Parallel Rod Connectors
- Applicant
- Blackstone Medical, Inc.
Wayne, NJ, US - Received
- February 14, 2008
- Decision date
- March 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K092624 | Firebird Spinal Fixation SystemNKB · Special | 09/25/2009SE |
| K082797 | Blackstone Pedicle Screw SystemNKB · Special | 10/17/2008SE |
| 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 |
| K081177 | Blackstone Medical, Inc., Pillar Spacer SystemMAX · Traditional | 07/23/2008SE |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemKWP · Special | 03/13/2008SE |
| K073420 | Blackstone Ascent Multiaxial ScrewsKWP · Special | 02/14/2008SE |
Questions and answers
When was Blackstone SFS Parallel Rod Connectors cleared by the FDA?
Blackstone SFS Parallel Rod Connectors (K080407) received a 510(k) decision of Substantially Equivalent on March 13, 2008, 28 days after the submission was received.
What is the product code of K080407?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.