Data / Medical devices / United States / Innomed, Inc.
Innomed, Inc.: FDA-registered device maker in Savannah, GA, United States, 1 510(k) clearance
Innomed, Inc. is registered with the FDA (registration 1833053) in Savannah, GA, United States. It lists 48 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 3, 1994. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1833053
- Address
- 103 Estus Dr, Savannah, GA, United States, 31404
- Owner or operator
- INNOMED, INC. (1833053)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 20, 2001
- Registered through
- 2026
- Brand names listed
- AK Fracture Reducer, Assistant Free 5" Wide Standard Blade, Bone Holding Reduction Double Curved Clamp, Browner Wire Tightener, Case Tray Nicholson Shoulder Extractor, Deorio Calcaneal Z-Osteotomy Guide, LED Disposable Light Source (package of 10), O'BRIEN CHEVRON CLAMP-LEFT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Specification developer | accessdata.fda.gov |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Specification developer | accessdata.fda.gov |
| Adaptor, Holder, Syringe | IQG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Cannula | FKC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Specification developer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Specification developer | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Specification developer | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Specification developer | accessdata.fda.gov |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | 1 | Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | 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 3, 1994 | K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | FCW | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 7, 2024 | 94337 | Class II | Completed | INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup | 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade. | accessdata.fda.gov |
Compare with other makers
- All makers of Rasp, Surgical, General & Plastic Surgery
- All makers of Impactor
- All makers of Elevator
- All makers of Accessories, Arthroscopic
- All makers of Light Source, Fiberoptic, Routine
- All makers of Extractor
Updated May 1, 2024. 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.