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Sign in to claim this brandSPINAL ELEMENTS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3115 Melrose Dr Suite 200, CARLSBAD, CA, 92010
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004893332
- DUNS Number
- —
Catalogue (13338)
Page 2 of 267| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Omni | LCPT 80-K | FDA UDI | Class II | Active |
| Diamond | 10003-F-4014 | FDA UDI | Class II | Unknown |
| Luna | LUN28011 | FDA UDI | Class I | Active |
| Lucent Xp | 11014-557 | FDA UDI | Class I | Active |
| Ventana L | 42250-808 | FDA UDI | Class II | Active |
| Lucent L | 81164-188 | FDA UDI | Class I | Active |
| Lucent L | 12201-620 | FDA UDI | Class I | Active |
| Phenix | 8178-10S-05P | FDA UDI | Class I | Unknown |
| Zeus-O | 10101-1228 | FDA UDI | Class I | Active |
| Talon | RTS07080 | FDA UDI | Class II | Active |
| Ventana C | 42014-112 | FDA UDI | Class II | Active |
| Ventana C | 41411-206 | FDA UDI | Class II | Active |
| Crystal | 20029-012 | FDA UDI | Class I | Active |
| Crystal | 20000-000-87 | FDA UDI | Class I | Active |
| Mercury | 64001-000-08 | FDA UDI | Class I | Active |
| Savannah | 9004-A | FDA UDI | Class I | Active |
| Overwatch | 108-847-01 | FDA UDI | Class I | Active |
| Overwatch | 108-RS-6535DC | FDA UDI | Class II | Active |
| Zeus-P | 65-300911 | FDA UDI | Class II | Active |
| Savannah-T | 10-02-7535-1 | FDA UDI | Class II | Active |
| Phenix | 8178-1412SX-08L | FDA UDI | Class I | Unknown |
| Overwatch | 108-L-5525 | FDA UDI | Class II | Active |
| Overwatch | 108-L-8540 | FDA UDI | Class II | Active |
| Vertu | 52815-007 | FDA UDI | Class II | Active |
| Lotus | 31025-000 | FDA UDI | Class I | Active |
| Talon | ST08090 | FDA UDI | Class II | Active |
| Crystal | 20022-009 | FDA UDI | Class I | Active |
| Magnum+ | 15729-614 | FDA UDI | Class I | Active |
| Lucent L | 11120-000 | FDA UDI | Class I | Active |
| Lotus | 32518-038 | FDA UDI | Class II | Active |
| Mercury | 63001-000-60 | FDA UDI | Class I | Active |
| Lucent | P11855-610A | FDA UDI | Class II | Active |
| Issys | 062365 | FDA UDI | Class II | Unknown |
| Lucent L | P11850-216 | FDA UDI | Class II | Active |
| Lucent L | 11824-012 | FDA UDI | Class I | Active |
| Lucent | P10227-013 | FDA UDI | Class II | Active |
| Mercury | 63275-045 | FDA UDI | Class II | Active |
| Mosaic | 25040-016 | FDA UDI | Class II | Unknown |
| Zeus-L | 16-101840-L | FDA UDI | Class II | Active |
| Ceres-C | 08-171-1006 | FDA UDI | Class II | Active |
| Magnum+ | 15026-611 | FDA UDI | Class I | Active |
| Lucent | 11000-000-40 | FDA UDI | Class I | Active |
| Sapphire | 27045-016 | FDA UDI | Class II | Active |
| Sapphire X | 27022-030 | FDA UDI | Class I | Active |
| Lucent L | P11845-608 | FDA UDI | Class II | Active |
| Amendia | 10-03-6550-2 | FDA UDI | Class II | Active |
| Lucent L | 12230-600-03 | FDA UDI | Class I | Active |
| Lucent L | P12245-208 | FDA UDI | Class II | Active |
| Lucent | P10822-509 | FDA UDI | Class II | Active |
| Lucent L | 11804-612 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (24)
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 |
|---|---|---|---|---|
| Apr 16, 2018 | Z-1912-2018 | — | open, classified | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. |
| Apr 9, 2015 | Z-1597-2015 | — | terminated | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device. |
| Dec 18, 2014 | Z-0907-2015 | — | terminated | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. |
| Apr 17, 2009 | Z-1253-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1264-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1254-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1255-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1249-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1266-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1259-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1246-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1260-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1256-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1265-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1252-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1248-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1261-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1257-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1263-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1250-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1258-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1247-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1262-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Z-1251-2013 | — | terminated | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |