Sapphire Medical Group: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sapphire Medical Group” (first 2012, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 78 days, against 98 days for all cleared 510(k)s in the same product codes. 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 | 1 | 203 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 58 |
| 2018 | 0 | — |
| 2019 | 2 | 75 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 203 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sapphire Medical Group took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Sapphire Medical Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232619 | MATRIX HA PEEK Cervical IBF System | ODP | 2024-03-19 | 203 |
| K192316 | Matrix HA PEEK Cervical Implant System | ODP | 2019-10-17 | 52 |
| K183073 | SMG Anterior Cervical Plate System | KWQ | 2019-02-11 | 98 |
| K172674 | Sapphire Cervical Implant System | ODP | 2017-11-02 | 58 |
| K121693 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) | MAX | 2012-12-27 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Sapphire Medical Group.
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.
- Sapphire Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sapphire Medical Group?
FDA lists 5 510(k) clearances under the applicant name “Sapphire Medical Group” (first 2012, latest 2024), across 3 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 Sapphire Medical Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sapphire Medical Group is 98 days. Since 2017: 78 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sapphire Medical Group?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 5 Sapphire Medical Group clearances with predicates and recalls
- Run predicate analysis for product code ODP, Sapphire Medical Group'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.