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SURGICAL THEATER LLC

Last updated May 27, 2026

What SURGICAL THEATER LLC makes

Surgical Theater LLC makes surgical planning and navigation-enhancement systems, surgical simulation systems, and related visualization tools for clinical and preoperative use. Their products include SpineAR SNAP, Endo SNAP, SyncAR SNAP, SRP BrainStorm, All-in-One Clinic Viewer, SNAP Desktop, SNAP Patient Engagement, Notebook Clinic Viewer, SNAP OR, SRP, SNAP Mini Desktop, and the Surgery Rehearsal Platform.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Surgical Theater LLC make?

Surgical Theater LLC makes surgical planning and navigation-enhancement systems, surgical simulation systems, and related visualization tools for clinical and preoperative use, including products such as SpineAR SNAP, Endo SNAP, SyncAR SNAP, SRP BrainStorm, All-in-One Clinic Viewer, SNAP Desktop, SNAP Patient Engagement, Notebook Clinic Viewer, SNAP OR, SRP, SNAP Mini Desktop, and the Surgery Rehearsal Platform.

Where is Surgical Theater LLC based?

Surgical Theater LLC is based in the United States, as stated in the provided summary which identifies the company's country as US.

Which registries list Surgical Theater LLC's devices?

Surgical Theater LLC's devices are listed in the FDA 510(k) and FDA UDI registries, as explicitly stated in the device data under the LISTED IN field.

How are Surgical Theater LLC's devices classified?

Surgical Theater LLC's devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field of the provided data, which indicates their regulatory risk level without implying company-wide approval.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: surgicaltheater.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 330-472-6520
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 071341647

Catalogue (19)

Device	Model / Reference	Registries	Class	Status
SpineAR SNAP	SpineAR	FDA UDI	Class II	Active
Endo SNAP	Endo SNAP	FDA UDI	Class II	Active
SyncAR SNAP	SyncAR	FDA UDI	Class II	Active
SRP BrainStorm	BrainStorm	FDA UDI	Class II	Active
All-in-One Clinic Viewer	All-in-One	FDA UDI	Class II	Active
SNAP Desktop	VR SNAP	FDA UDI	Class II	Active
SNAP Patient Engagement	PE SNAP	FDA UDI	Class II	Active
Notebook Clinic Viewer	Notebook	FDA UDI	Class II	Active
Snap Or	SNAP	FDA UDI	Class II	Active
Srp	SRP	FDA UDI	Class II	Active
SNAP Mini Desktop	VR MSNAP	FDA UDI	Class II	Active
Surgery Rehearsal Platform	K123023	FDA 510(k)	Class II	Active
SpineAR SNAP (SyncAR Spine)	K243623	FDA 510(k)	Class II	Active
SpineAR SNAP	K213034	FDA 510(k)	Class II	Active
SuRgical Planner (SRP) BrainStorm	K201465	FDA 510(k)	Class II	Active
SuRgical Planner (SRP)	K170793	FDA 510(k)	Class II	Active
SpineAR SNAP (SyncAR Spine)	K252054	FDA 510(k)	Class II	Active
Surgical Navigation Advanced Platform (SNAP)	K160584	FDA 510(k)	Class II	Active
Surgical Navigation Advanced Platform	K140819	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 7 recall records for SURGICAL THEATER LLC, all initiated on 2025-09-16. The statuses of these recalls are recorded as open and classified. The reason given for the recalls is a software anomaly that may lead to misalignment of secondary image layers to the primary image layer under specific conditions involving large rotational alignment values in 2D Image Fusion.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 16, 2025	Z-0322-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0319-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0323-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0321-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0324-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0325-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Sep 16, 2025	Z-0320-2026	—	open, classified	A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.