7D Surgical System (10-0001)
7D Surgical ULC · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Toronto
- Advisory committee description
- Neurology
- Address 1
- 60 Scarsdale Rd., Unit 118
- Statement or summary
- Summary
- Product code
- OLO
- Zip code
- M3B 2R7
- Applicant
- 7D Surgical ULC
- Decision date
- 2026-10-19
- Decision code
- SESE
- Country code
- CA
- Device name
- 7D Surgical System (10-0001)
- Advisory committee
- NE
- Contact
- Elena Marenny
- K number
- K260403
- Date received
- 2026-02-06
- Review advisory committee
- OR
- Postal code
- M3B 2R7
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Orthopedic Stereotaxic Instrument
- Medical specialty description
- Neurology
- Regulation number
- 882.4560
- Device class
- 2
- Registration number
- 3027153110, 9617297, 1226544, 2027487, 3009493875, 3010047402, 3007993775, 3007485169, 1314417, 3010009632, 3003139373, 3006846753, 3009554293, 3009871135, 3005819474, 3006563559, 3004727093, 3015869121, 3043543260, 3026576110, 2531477, 3036756245, 3008027912, 3034676720, 1218017, 3006654680, 3010039400, 1828288, 3015941638, 3014680149, 3005751028, 3001284227, 3024999441, 3010822102, 1421101, 3016443334, 3010120326, 3004893332, 3021902355, 2530808 +350 more
- FEI number
- 3027153110, 2027487, 3009493875, 3010047402, 3007993775, 1000139987, 3007485169, 1314417, 3007282753, 3010009632, 3003139373, 3002807231, 3006846753, 3009554293, 3009871135, 3005532635, 3005819474, 3006563559, 3003112432, 3004727093, 3008782585, 3015869121, 3043543260, 3026576110, 3002821504, 3002619595, 3036756245, 3008027912, 3034676720, 1218017, 3006654680, 3010039400, 1828288, 3005751028, 3014680149, 3001284227, 3024999441, 3010822102, 1421101, 3016443334 +350 more