LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS
FDA premarket approval P000058/S061 · decided 2016-08-11
Approval details
- PMA number
- P000058
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2016-07-11
- Decision date
- 2016-08-11
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NEK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Site change for a manufacturing supplier.
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510(k) clearances by this applicant
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|---|---|---|
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| Infinity™ OCT System (K253129) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |