| Primary Device ID | B756SBD0080 |
| NIH Device Record Key | c882c077-767f-4c08-b13f-72edc81dcf13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shukla Knee S9KNEE |
| Version Model Number | SBD008 |
| Catalog Number | SBD008 |
| Company DUNS | 159009294 |
| Company Name | Shukla Medical |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com | |
| Phone | +1-727-626-2770 |
| cs@shuklamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B756SBD0080 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
[B756SBD0080]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2020-11-16 |
| B756SXT0020 | Extractor Assy, Femoral Component |
| B756SXT0010 | Extractor Assembly, Tibial Component |
| B756SBD0030 | Movable Jaw (sub-assembly) |
| B756STP0480 | Jaw Tip, Knee Tibial Extractor, Replaceable |
| B756SSH0070 | Connector Shaft for Strike Plate |
| B756SOS001100 | Osteotome Assy, Z Shaped, 3/4" Reach, .313" Wide |
| B756SOS001090 | Osteotome Assy, Z Shaped, 1/2" Reach, .313" Wide |
| B756SOS001080 | Osteotome Assy, Retrograde, 3/4" Reach, .500" Wide |
| B756SOS001070 | Osteotome Assy, Retrograde, 1/2" Reach, .500" Wide |
| B756SOS001060 | Osteotome Assy, Retrograde, 3/4" Reach, .313" Wide |
| B756SOS001050 | Osteotome Assy, Retrograde, 1/2" Reach, .313" Wide |
| B756SMT0010 | Mallet Assembly, Grooved |
| B756SIN0010 | Handle Assy, Osteotome, Twist Lock |
| B756SCA1010 | Case & Tray, Knee System |
| B756SBD0080 | Strike Plate, Assy, Frame (C-Frame) |