Aesculap activL Artificial Disc
FDA premarket approval P120024/S011 · decided 2020-01-31
Approval details
- PMA number
- P120024
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Aesculap activL Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2019-12-06
- Decision date
- 2020-01-31
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- Approval forfollowing changes to the activL® Artificial Disc Enhanced Safety Surveillance Survey:1) Section: Pain Management; Question 4: Add N/A checkbox to the column, Using Spike Endplate as now it is possible that a Surgeon implanters experience would exclude the Spike Endplate and only include the Keel Endplate;2) Section: Spike vs. Keel Endplate Design; HeaderRemove For Surgeons Outside the US ONLY as now it is possible that a Surgeon implanter within the U.S. will have the option of the S
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |