Surgical Theater, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Surgical Theater, Inc.” (first 2013, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 90 days, against 126 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 |
|---|---|---|
| 2013 | 1 | 133 |
| 2014 | 1 | 87 |
| 2015 | 0 | — |
| 2016 | 1 | 119 |
| 2017 | 0 | — |
| 2018 | 1 | 333 |
| 2019 | 0 | — |
| 2020 | 1 | 45 |
| 2021 | 0 | — |
| 2022 | 1 | 373 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surgical Theater, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| SBF | Orthopedic Augmented Reality | 3 | 3 |
Review panels
- Radiology (5)
- Orthopedic (3)
Most recent Surgical Theater, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252054 | SpineAR SNAP (SyncAR Spine) | SBF | 2025-09-29 | 90 |
| K243623 | SpineAR SNAP (SyncAR Spine) | SBF | 2024-12-24 | 29 |
| K213034 | SpineAR SNAP | SBF | 2022-09-29 | 373 |
| K201465 | SuRgical Planner (SRP) BrainStorm | LLZ | 2020-07-17 | 45 |
| K170793 | SuRgical Planner (SRP) | LLZ | 2018-02-12 | 333 |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | LLZ | 2016-06-28 | 119 |
| K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM | LLZ | 2014-06-27 | 87 |
| K123023 | SURGERY REHEARSAL PLATFORM | LLZ | 2013-02-08 | 133 |
Recalls
7 product recalls in 1 recall events; 7 initiated in the last five years. Most recent: 2025-09-16.
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.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Theater, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Surgical Theater, Inc.” (first 2013, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgical Theater, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Theater, Inc. is 104 days. Since 2017: 90 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Surgical Theater, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5); SBF (Orthopedic Augmented Reality, 3).
Next steps
- See all 8 Surgical Theater, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Surgical Theater, 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, 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.