510(k) K243774
- Device
- ELID (Endoscopic Less Invasive Decompression) System
- Applicant
- Lesspine Innovations
- 510(k) number
- K243774
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-27
- Date received
- 2024-12-06
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Vito Lore
- Address
- 200 Summit Dr. Suite 505 Burlington MA US 01803 01803
FDA Registration Numbers
- 1450662
- 3030926959
- 1416980
- 3009394448
- 3011277660
- 3004464325
- 3001239363
- 1421101
- 3015453963
- 2183744
- 3013188547
- 1834331
- 3012809732
- 9612074
- 3002807112
- 2032521
- 2649614
- 2031093
- 3030447506
- 3001556604
- 1643264
- 3011050570
- 3027262786
- 2085947
- 3003704957
- 3033589330
- 3006950086
- 3003678543
- 3027339877
- 8010877
- 1625507
- 3017210488
- 3002807314
- 1045254
- 2916714
- 8010177
- 3007113251
- 3007305485
- 3030733800
- 3033536319
- 3010331645
- 3006142527
- 3002808022
- 1030489
- 9613793
- 3015173212
- 1526611
- 3007421149
- 3009499159
- 2183449
- 9617616
- 3014579161
- 3014202166
- 8010418
- 1061927
- 3018242561
- 3005083075
- 2081135
- 3012790575
- 3007495879
- 3010432890
- 3030446844
- 3004734264
- 3005254598
- 3009973505
- 3004215117
- 3014200871
- 1221934
- 9614841
- 3012447612
- 9617601
- 3021336182
- 3020978007
- 3018821071
- 3009756153
- 9610617
- 3017396949
- 3014232239
- 1032347
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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