The following data is part of a premarket notification filed by Gpc Medical Limited with the FDA for Gpc Brand Posterior, Non Cervical Pedicle Screw Spinal System.
| Device ID | K163096 |
| 510k Number | K163096 |
| Device Name: | GPC BRAND Posterior, Non Cervical Pedicle Screw Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GPC MEDICAL LIMITED GPC SQUARE, M-BLOCK, DDA, LSC, VIKAS PURI New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC MEDICAL LIMITED GPC SQUARE, M-BLOCK, DDA, LSC, VIKAS PURI New Delhi, IN 110018 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-03-31 |
| Summary: | summary |