Data / Medical devices / United States / RSB Spine LLC.
RSB Spine LLC.: FDA-registered device maker in Wooster, OH, United States, 6 510(k) clearances
RSB Spine LLC. is registered with the FDA (registration 3003597504) in Wooster, OH, United States. It lists 52 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 27, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003597504
- Address
- 1877 Eagle Pass, Wooster, OH, United States, 44691
- Owner or operator
- RSB SPINE LLC. (9048490)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 1, 2007
- Registered through
- 2026
- Brand names listed
- InterPlate, InterPlate C-PS, InterPlate C-Ti, InterPlate L-PS, InterPlate L-Ti, InterPlate Spacer C-PS, InterPlate Spacer L-PS, Redmed and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Speculum, Ent | KAG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Skull | GXJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Orthopedic | HXR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Specula Accessories | FXG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Illuminated | FXF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Non-Illuminated | FXE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 27, 2010 | K092540 | C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER | ODP | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
| October 6, 2009 | K092070 | INTERPLATE C | KWQ | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
| May 29, 2008 | K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | OVE | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
| September 18, 2007 | K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | OVD | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
| June 11, 2007 | K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | MQP | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
| April 19, 2007 | K070316 | INTERPLATE VBR SYSTEM | MQP | Substantially Equivalent | Rsb Spine, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Speculum, Ent
- All makers of Clamp
- All makers of Hook, Bone
- All makers of Instrument, Surgical, Disposable
- All makers of Speculum, Non-Illuminated
- All makers of Orthopedic Manual Surgical Instrument
Updated January 27, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.