Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Spineart with 58 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Aug 20, 2026: SCALA® TL.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 20, 2026 | SCALA® TLK261049 · MAX | 510(k) clearances |
| Aug 14, 2026 | BAGUERA® C Cervical Disc Surgical InstrumentsK262639 · QLQ | 510(k) clearances |
| Jul 29, 2026 | SPINEART Navigation Instrument SystemK261205 · OLO | 510(k) clearances |
| May 1, 2026 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemK253966 · NKB | 510(k) clearances |
| Apr 9, 2026 | SPINEART Navigation Instrument SystemK254158 · OLO | 510(k) clearances |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: NoClass II · Cannulated fenestrated polyaxial screws may be incorrectly labeled | Device recalls |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: NoClass II · Cannulated fenestrated polyaxial screws may be incorrectly labeled | Device recalls |
| Jun 18, 2025 | SPINEART Navigation Instrument SystemK242933 · OLO | 510(k) clearances |
| Mar 7, 2025 | SPINEART Navigation Instrument SystemK242890 · OLO | 510(k) clearances |
| Oct 23, 2024 | Scarlet® AL-TK242589 · MAX | 510(k) clearances |
| Mar 15, 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TClass II · Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involve | Device recalls |
| Mar 16, 2023 | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JClass II · JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the prepa | Device recalls |
| Apr 9, 2021 | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is liClass II · Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. | Device recalls |
| Feb 5, 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal proceduresClass III · Inner blister pack label is incorrect and does not match the correct external box label. | Device recalls |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Class II · Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a se | Device recalls |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Class II · Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a se | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
