Titan Spine, LLC: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Titan Spine, LLC” (first 2008, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 105 days. Since 2017 the median was 72 days, against 107 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 101 |
| 2015 | 3 | 111 |
| 2016 | 0 | — |
| 2017 | 2 | 145 |
| 2018 | 1 | 90 |
| 2019 | 4 | 41 |
| 2020 | 1 | 208 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Titan Spine, LLC took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
Review panels
- Orthopedic (19)
Most recent Titan Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | 2020-01-08 | 208 |
| K192054 | Endoskeleton TAS Plate | OVD | 2019-08-29 | 29 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | ODP | 2019-08-16 | 18 |
| K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | 2019-08-06 | 54 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | ODP | 2019-02-11 | 53 |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | 2018-02-13 | 90 |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | MAX | 2017-07-06 | 147 |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | 2017-04-13 | 143 |
| K153122 | Endoskeleton(r) TCS System | OVE | 2015-12-14 | 46 |
| K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | 2015-10-09 | 119 |
9 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2015-07-20.
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.
- Titan Implants, Inc. (4 510(k)s)
- Titan Tables (4 510(k)s)
- Titan Medical, Inc. (3 510(k)s)
- Titan Mfg., Inc. (3 510(k)s)
- Titan Condoms, LLC (2 510(k)s)
- Titan Manufacturing, Inc. (1 510(k)s)
- Titan Technology Intl., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Titan Spine, LLC?
FDA lists 19 510(k) clearances under the applicant name “Titan Spine, LLC” (first 2008, latest 2020), across 4 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 Titan Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Titan Spine, LLC is 105 days. Since 2017: 72 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Titan Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4).
Next steps
- See all 19 Titan Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Titan Spine, LLC'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.