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Sign in to claim this brandCentinel Spine, LLC
United States·US-MF-000013245
Last updated September 17, 2026
Information
- Country
- United States
- Address
- Suite 3B, 900 Airport Road, PA, United States
- Website
- www.centinelspine.com/
- —
- —
- [email protected]
- Phone
- 0049 7333 925 99 80
- PRRC Contact
- Hoda El Outmani
- EUDAMED SRN
- US-MF-000013245
- FDA FEI Number
- 3007494564
- DUNS Number
- —
Catalogue (993)
Page 9 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pct | PCT0235045 | FDA UDI | Class II | Active |
| Midline Ii | M361508 | FDA UDI | Class II | Active |
| Midline Ii | M421112 | FDA UDI | Class II | Active |
| Midline Ii | M421520 | FDA UDI | Class II | Active |
| Pct | PCT0335195 | FDA UDI | Class II | Active |
| STALIF C-Ti | C168569-3Tc | FDA UDI | Class II | Active |
| Midline Ii | M331912 | FDA UDI | Class II | Active |
| Pct | PCT0245045 | FDA UDI | Class II | Active |
| Stalif L | STL4512-00 | FDA UDI | Class II | Active |
| Pct | PCT0135039 | FDA UDI | Class II | Active |
| Midline Ii | M332120 | FDA UDI | Class II | Active |
| MIDLINE II-Ti | M331312c | FDA UDI | Class II | Active |
| Stalif C | C146551-3D-I | FDA UDI | Class II | Active |
| Pct | PCT05DMT15 | FDA UDI | Class II | Active |
| Pct | PCT0335040 | FDA UDI | Class II | Active |
| Pct | PCT0435040 | FDA UDI | Class II | Active |
| Stalif L | STL4520 | FDA UDI | Class II | Active |
| Pct | PCT0140047 | FDA UDI | Class II | Active |
| Stalif L | STL4516-12 | FDA UDI | Class II | Active |
| STALIF C-Ti | C126551-3Dc | FDA UDI | Class II | Active |
| Prodisc C | 09.820.027S | FDA UDI | Class III | Active |
| Stalif Midline | STM6030 | FDA UDI | Class II | Active |
| Stalif C | C161299-3D | FDA UDI | Class II | Active |
| STALIF C-Ti | C127561-3Tc | FDA UDI | Class II | Active |
| Pct | PCT0240043 | FDA UDI | Class II | Active |
| Stalif C | C169579-3D | FDA UDI | Class II | Active |
| Pct | PCT0440055 | FDA UDI | Class II | Active |
| MIDLINE II-Ti | M391312c-35 | FDA UDI | Class II | Active |
| MIDLINE II-Ti | M301912c | FDA UDI | Class II | Active |
| Midline Ii | M331312 | FDA UDI | Class II | Active |
| Midline Ii | M301516 | FDA UDI | Class II | Active |
| Pct | PCT0335105 | FDA UDI | Class II | Active |
| Midline Ii | M391720 | FDA UDI | Class II | Active |
| Pct | PCT0335120 | FDA UDI | Class II | Active |
| Stalif C | ABS1540 | FDA UDI | Class II | Active |
| Pct | PCT0140050 | FDA UDI | Class II | Active |
| Pct | PCT0335135 | FDA UDI | Class II | Active |
| Stalif C | RAB1740 | FDA UDI | Class II | Active |
| Pct | PCT0435120 | FDA UDI | Class II | Active |
| Prodisc L | PDL-L-PT12S | FDA UDI | Class III | Active |
| Pct | PCT0140049 | FDA UDI | Class II | Active |
| Stalif C | C161189-3T | FDA UDI | Class II | Active |
| Pct | PCT0135026 | FDA UDI | Class II | Active |
| MIDLINE II-Ti | M301916c | FDA UDI | Class II | Active |
| Prodisc L | PDL-M-SP03S | FDA UDI | Class III | Active |
| Pct | PCT0135029 | FDA UDI | Class II | Active |
| Stalif L | STL4514-00 | FDA UDI | Class II | Active |
| Prodisc C Nova | PDNLD7 | FDA UDI | Class III | Active |
| Midline Ii | M301320 | FDA UDI | Class II | Active |
| Midline Ii | M391316 | FDA UDI | Class II | Active |
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 20, 2026 | Z-2051-2026 | — | open, classified | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. |
| Mar 20, 2026 | Z-2050-2026 | — | open, classified | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. |
| Dec 31, 2025 | Z-1426-2026 | — | open, classified | Products were mislabeled as the 6mm product but included the 5 mm product. |
| Jul 18, 2024 | Z-3212-2024 | — | open, classified | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations. |
| Jul 18, 2024 | Z-3213-2024 | — | open, classified | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations. |
| Mar 5, 2021 | Z-1406-2021 | — | terminated | Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product. |