SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| SURGICAL SOLUTIONS, LLC | 5 | Y | 2026-01-01 | 7400 College Blvd Ste 355 Overland Park KS US 66210 | ||
| 1062475 | 3000215692 | SURGICARE SUPPLIES INC. | 1 | Y | 2026-01-01 | 746 Tucker Road Winder GA US 30680 |
| 1125236 | 3001236105 | SURGICAL DESIGN, INC. | 1 | Y | 2026-01-01 | 7351-D LOCKPORT PL. LORTON VA US 22079 |
| 1219153 | 1219153 | SURGICAL TOOLS, INC. | 1 | Y | 2026-01-01 | 668 Orange St Bedford VA US 24523 |
| 1450781 | 1450781 | SURGICAL INSTRUMENT SERVICE CO. | 1 | N | 2026-01-01 | 151 North Brandon Glendale Heights IL US 60139 |
| 1511629 | 1511629 | SURGICAL APPLIANCE INDUSTRIES, INC. | 1 | N | 2026-01-01 | 3960 ROSSLYN DR. CINCINNATI OH US 45209 |
| 1825527 | 1825527 | SURGICAL TECHNOLOGY LABORATORIES INC. | 1 | N | 2026-01-01 | 1566 Whiting Way Lugoff SC US 29078 |
| 1935627 | 1935627 | SURGICAL INSTRUMENT MANUFACTURERS, LLC | 1 | N | 2026-01-01 | 2076 Fenton Logistics Park FENTON MO US 63026 |
| 2183319 | 2183319 | SURGICAL TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 292 EAST LAFAYETTE FRONTAGE RD ST. PAUL MN US 55107 |
| 9680952 | 3002808173 | SURGICAL INNOVATIONS LTD | 1 | N | 2026-01-01 | CLAYTON WOOD HOUSE 6 CLAYTON WOOD BANK LEEDS GB LS16 6QZ |
| 3003687489 | 3003687489 | SURGICAL DIRECT, INC. | 1 | Y | 2026-01-01 | 811 Harley Strickland Blvd Orange City FL US 32763 |
| 3004044817 | 3004044817 | SURGICAL PRINCIPALS, INC. - SPI | 1 | Y | 2026-01-01 | 1625 South Tacoma Way Tacoma WA US 98409 |
| 3004957147 | 3004957147 | SURGICAL TABLES INCORPORATED | 1 | N | 2026-01-01 | 2 Debush Avenue BUILDING C UNIT 3 MIDDLETON MA US 01949 |
| 3008643361 | 3008643361 | SURGICAL SOLUTIONS JA PR INC | 1 | Y | 2026-01-01 | 628 Calle Aldebaran Urb Altamira San Juan PR US 00920 |
| 3008869747 | 3008869747 | SURGICAL PLANNING ASSOCIATES | 1 | N | 2026-01-01 | New England Baptist Hospital 125 Parker Hill Ave Suite 545 Boston MA US 02120 |
| 3010056241 | 3010056241 | SURGICAL ESTHETICS BIOMEDICAL TECHNOLOGIES | 1 | Y | 2026-01-01 | 19355 Business Center Drive Suite 8 Northridge CA US 91324 |
| 3010197287 | 3010197287 | SURGICAL THEATER, INC. | 1 | N | 2026-01-01 | 23645 Mercantile Road Suite M Beachwood OH US 44122 |
| 3014110984 | 3014110984 | SURGICAL DYNAMICS LTD | 1 | N | 2026-01-01 | Unit 35A Werdohl Way Number One Industrial Estate Consett Durham GB DH8 6SZ |
| 3015194982 | 3015194982 | SURGICAL INNOVATION ASSOCIATES, INC. | 1 | N | 2026-01-01 | 445 W Erie St Suite 111 Chicago IL US 60654 |
| 3016597885 | 3016597885 | SURGICAL INSTRUMENT INNOVATIONS | 1 | Y | 2026-01-01 | 3901 W Van Buren St. Suite 210/220 Phoenix AZ US 85009 |
| 3021159358 | 3021159358 | SURGICAL REPUBLIC | 1 | N | 2026-01-01 | 428 MAIN ST STE 205 Huntington Beach CA US 92648 |
| 3022472578 | 3022472578 | SURGICAL FUSION INC. | 1 | Y | 2026-01-01 | 930 Sylvan Ave, Suite 125 Englewood Cliffs NJ US 07632 |
| 3022518322 | 3022518322 | SURGICAL FUSION TECHNOLOGIES GmbH | 1 | N | 2026-01-01 | Wagistrasse 6 Schlieren Zurich CH 8952 |
| 3027080417 | 3027080417 | SURGICAL RADIATION PRODUCTS LLC | 1 | N | 2026-01-01 | 700 US Highway One Suite D North Palm Beach FL US 33408 |
| 3043622938 | 3043622938 | SURGICAL HEALTH SOLUTIONS, INC | 1 | N | 2026-01-01 | 177 Townes Ct Dripping Springs TX US 78620 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3966 | 1740741027 | K983756 | SURGIFORM ANATOMICAL MALAR | LZK | 1998-11-20 |
| 3966 | 1275533112 | K983755 | NASAL DORSAL SERIES | FZE | 1998-11-20 |
| 3966 | 1278108058 | K983754 | STANDARD CHIN | FWP | 1998-11-20 |
| 60684 | 1101706611 | K974382 | ACKERMANN SURGICAL INSTRUMENTS | GCJ | 1998-04-21 |
| 60684 | 1434266412 | K932938 | ELMED ESU 300 M/M AND DIGITAL | GEI | 1994-05-02 |
| 60684 | 2013548300 | K926517 | ELMED LBC 50-P | HIN | 1994-11-15 |
| 157824 | 1598164596 | K252054 | SpineAR SNAP (SyncAR Spine) | SBF | 2025-09-29 |
| 237644 | 1378489926 | K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | GCJ | 2025-09-22 |
| 305091 | 1461278742 | K240288 | SF Push- in Anchor | MAI | 2024-04-01 |
| 305097 | 2010050553 | K240288 | SF Push- in Anchor | MAI | 2024-04-01 |
| 125430 | 1572196652 | K233315 | HipXpert and HipInsight System | OSF | 2024-08-08 |
| 347929 | 1053500597 | K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | FRO | 2024-05-31 |
| 237644 | 1047741328 | K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | GEI | 2021-08-16 |
| 14410 | 1206629891 | K210495 | Port Access System | GCJ | 2021-06-18 |
| 157824 | 1713361138 | K201465 | SuRgical Planner (SRP) BrainStorm | LLZ | 2020-07-17 |
| 125430 | 1574562582 | K200384 | HipXpert 3D Display and Anchoring Application | OSF | 2021-01-28 |
| 60684 | 1187916063 | K193018 | Surgical Direct Hand-held Laparoscopic Instruments | GEI | 2019-12-20 |
| 31765 | 1340934712 | K192234 | ActiPatch | PQY | 2020-01-31 |
| 14410 | 1096661674 | K190592 | YelloPort Elite Port Access System | GCJ | 2019-04-29 |
| 314110 | 1929353609 | K181094 | Polydioxanone Surgical Scaffold | FTL | 2018-08-02 |
| 316034 | 1434024555 | K180027 | ACCUSYTE 3D Fiducial Marker | IYE | 2018-07-18 |
| 305091 | 1575185108 | K171228 | Fiji Anchor | MAI | 2018-01-19 |
| 305097 | 1933291906 | K171228 | Fiji Anchor | MAI | 2018-01-19 |
| 157824 | 1815942079 | K170793 | SuRgical Planner (SRP) | LLZ | 2018-02-12 |
| 3966 | 1624375345 | K170582 | Saf-T-Vac Smoke and Fluid Evacuator | GEI | 2017-04-14 |
| 157824 | 1356244403 | K160584 | Surgical Navigation Advanced Platform (SNAP) | LLZ | 2016-06-28 |
| 347929 | 1810826131 | K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | FRO | 2015-11-19 |
| 60684 | 1379070890 | K143221 | Schoelly Laparoscope | GCJ | 2014-12-05 |
| 14410 | 1698804351 | K123110 | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 | GCJ | 2013-01-17 |
| 31765 | 1253463504 | K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | DWL | 2012-04-27 |
| 14410 | 1409235707 | K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | GEI | 2012-01-26 |
| 14410 | 1166024579 | K100442 | FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM | GCJ | 2010-09-07 |
| 14410 | 1364420921 | K100109 | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE | GCJ | 2010-07-15 |
| 125430 | 1681514512 | K093491 | HIP SEXTANT INSTRUMENT SYSTEM | OSF | 2010-12-09 |
| 3966 | 1070227152 | K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | FWP | 2009-04-22 |
| 14410 | 1907916708 | K070712 | MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM | GCJ | 2007-03-28 |
| 14410 | 1328898700 | K063485 | LOGIC LAPAROSCOPIC SCISSORS | GEI | 2006-12-01 |
| 60684 | 1435362216 | K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | FAJ | 2007-03-02 |
| 3966 | 1274752323 | K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | KKY | 2002-10-16 |
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| 33798 | 1298855279 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GCJ | 9 | 2025-09-22 |
| GEI | 6 | 2021-08-16 |
| MAI | 4 | 2024-04-01 |
| OSF | 3 | 2024-08-08 |
| LLZ | 3 | 2020-07-17 |
| FRO | 2 | 2024-05-31 |
| FWP | 2 | 2009-04-22 |
| SBF | 1 | 2025-09-29 |
| PQY | 1 | 2020-01-31 |
| FTL | 1 | 2018-08-02 |
| IYE | 1 | 2018-07-18 |
| DWL | 1 | 2012-04-27 |
| FAJ | 1 | 2007-03-02 |
| KKY | 1 | 2002-10-16 |
| LZK | 1 | 1998-11-20 |
| FZE | 1 | 1998-11-20 |
| HIN | 1 | 1994-11-15 |
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