Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
K233839 is the FDA 510(k) clearance record for Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system, a class II device, cleared for Gbs Commonwealth Co., Ltd. on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 14 510(k) clearances for Gbs Commonwealth Co., Ltd., from to . As of , FDA records show no recalls naming K233839.
Clearance record
- Decision date
- Received
- (16 days to decision)
- Product code
- ODP Intervertebral Fusion Device With Bone Graft, Cervical
- Regulation
- 21 CFR 888.3080
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Gbs Commonwealth Co., Ltd. C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro, Geumcheon-Gu, KR
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code ODP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 3 |
| December 2025 | 2 |
| January 2026 | 5 |
| February 2026 | 1 |
| March 2026 | 2 |
| April 2026 | 4 |
| May 2026 | 2 |
| June 2026 | 0 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 0 |
| October 2026 | 0 |
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