Blackstone Medical, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Blackstone Medical, Inc.” (first 1997, latest 2010), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 61 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 13 | 13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 7 | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (45)
Most recent Blackstone Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093926 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | 2010-07-28 | 218 |
| K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES | KWQ | 2010-05-04 | 61 |
| K092624 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | 2009-09-25 | 30 |
| K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | 2008-10-17 | 24 |
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | 2008-09-15 | 90 |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | MAX | 2008-09-04 | 28 |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | OVD | 2008-08-28 | 59 |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | MAX | 2008-07-23 | 89 |
| K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS | MNI | 2008-03-13 | 28 |
| K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM | KWP | 2008-03-13 | 29 |
35 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2010-04-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Blackstone (1 510(k)s)
- Blackstone & Breglio Industries (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blackstone Medical, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Blackstone Medical, Inc.” (first 1997, latest 2010), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Blackstone Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blackstone Medical, Inc. is 61 days.
Which FDA product codes appear under Blackstone Medical, Inc.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 13); KWP (Appliance, Fixation, Spinal Interlaminal, 7); MNI (Orthosis, Spinal Pedicle Fixation, 7).
Next steps
- See all 45 Blackstone Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Blackstone Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.