NUVASIVE PCM CERVICAL DISC SYSTEM
FDA premarket approval P100012 · decided 2012-10-26
Approval details
- PMA number
- P100012
- Trade name
- NUVASIVE PCM CERVICAL DISC SYSTEM
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Nuvasive, Inc.
- Date received
- 2010-04-01
- Decision date
- 2012-10-26
- Days to decision
- 939 days
- Decision code
- APWD
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE PCM CERVICAL DISC SYSTEM. THIS DEVICE IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF A DEGENERATED CERVICAL DISC AT ONE LEVEL FROM C3-C4 TO C6-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT), WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE DISC SPACE, AND MANIFESTED BY AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING(CT, MRI,
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510(k) clearances by this applicant
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|---|---|---|
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| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
| NuVasive® VersaTie™ System (K173117) | Nuvasive, Inc. | 2017-12-07 |
| NuVasive CoRoent System (K141665) | Nuvasive, Inc. | 2015-03-13 |
| NuVasive X-CORE(R) Expandable VBR System (K142205) | Nuvasive, Inc. | 2015-02-20 |
| NUVASIVE NVM5 SYSTEM (K141968) | Nuvasive, Inc. | 2014-11-14 |
| COROENT TI-C SYSTEM (K140319) | Nuvasive, Inc. | 2014-10-09 |