Spine Smith Partners L.P.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Spine Smith Partners L.P.” (first 2008, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 | 2 | 90 |
| 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 | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Spine Smith Partners L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122630 | IN:C2 SPINAL FIXATION SYSTEM | OVE | 2012-12-05 | 99 |
| K122168 | VISUALIF CHALLENGING ACCESS PLATE | OVD | 2012-10-11 | 80 |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM | OVD | 2010-09-30 | 66 |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | MAX | 2010-07-01 | 73 |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | MAX | 2009-04-01 | 43 |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-10-31 | 36 |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-07-14 | 84 |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | MQP | 2008-07-02 | 89 |
| K073320 | CIMPLICITY SPINAL SYSTEM | ODP | 2008-02-07 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Spine Smith Partners L.P..
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.
- Spine Wave, Inc. (59 510(k)s)
- Spine Vision, Inc. (12 510(k)s)
- Spine View, Inc. (9 510(k)s)
- Spine Next America (5 510(k)s)
- Spine-Tech, Inc. (4 510(k)s)
- Spine Next SA (3 510(k)s)
- Spine Smith Holdings, LLC (3 510(k)s)
- Spine Innovation, LLC (2 510(k)s)
- Spine Works (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spine Smith Partners L.P.?
FDA lists 9 510(k) clearances under the applicant name “Spine Smith Partners L.P.” (first 2008, latest 2012), across 6 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 Spine Smith Partners L.P.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spine Smith Partners L.P. is 73 days.
Which FDA product codes appear under Spine Smith Partners L.P.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2).
Next steps
- See all 9 Spine Smith Partners L.P. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Spine Smith Partners L.P.'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.