SeaSpine Spacer System – Redondo™
Redondo Implant Caddy 34mm x 24mm, 12 Deg
1manufacturer
15catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RED388IMP | 38mm, 8° | In distribution |
| RED3412IMP | 34mm, 12° | In distribution |
| 93-6502 | 26mm | In distribution |
| 93-6513 | In distribution | |
| RED348IMP | 34mm, 8° | In distribution |
| 93-6503 | 30mm | In distribution |
| REDL0IMP | In distribution | |
| RED3812IMP | 38mm, 12° | In distribution |
| REDL8IMP | 8° | In distribution |
| REDIMP | In distribution | |
| 93-6505 | 34mm x 24mm, 12 Deg | In distribution |
| 93-6501 | In distribution | |
| 93-6506 | 38mm x 26mm, 8 Deg | In distribution |
| 93-6507 | 38mm x 26mm, 12 Deg | In distribution |
| 93-6504 | 34mm x 24mm, 8 Deg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
Showing 12 of 367. All products under Orthopedic Tray
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.