| Primary Device ID | 04719872144342 |
| NIH Device Record Key | b29a2e03-13dc-4a3d-a784-3e030ccb53a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Conformity Stem |
| Version Model Number | 9110-7008 |
| Catalog Number | 9110-7008 |
| Company DUNS | 656700556 |
| Company Name | UNITED ORTHOPEDIC CORP. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872144342 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
[04719872144342]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-06 |
| Device Publish Date | 2022-06-28 |
| 04711605586573 | Neck trial, STD, 135° |
| 04711605587105 | Conformity sharp broach case, #1~#5 |
| 04711605587099 | Conformity MIS case |
| 04711605587082 | Hip stem basic case |
| 04711605587075 | Conformity stem case |
| 04711605586597 | Neck trial, high offset, 135° |
| 04711605585453 | Broach, #11 |
| 04711605585446 | Broach, #10 |
| 04711605585439 | Broach, #9 |
| 04711605585422 | Broach, #8 |
| 04711605585415 | Broach, #7 |
| 04711605585408 | Broach, #6 |
| 04711605585392 | Broach, #5 |
| 04711605585385 | Broach, #4 |
| 04711605585378 | Broach, #3 |
| 04711605585361 | Broach, #2 |
| 04711605585354 | Broach, #1 |
| 04711605587587 | Calcar reamer, large |
| 04711605587570 | Calcar reamer, small |
| 04711605586177 | Neck resection guide |
| 04711605587112 | Conformity sharp broach case, #6~#8 |
| 04719872145998 | Stem extractor |
| 04719872145592 | Neck template |
| 04719872145424 | Dual offset broach handle, right |
| 04719872145417 | Dual offset broach handle, left |
| 04719872145400 | Offset broach handle |
| 04719872145394 | Straight broach handle |
| 04719872144397 | Canal sizer, Ø18mm |
| 04719872144380 | Canal sizer, Ø16mm |
| 04719872144373 | Canal sizer, Ø14mm |
| 04719872144366 | Canal sizer, Ø12mm |
| 04719872144359 | Canal sizer, Ø10mm |
| 04719872144342 | Canal sizer, Ø8mm |
| 04719872144335 | Restrictor inserter |
| 04711605587976 | Dual offset broach handle, right |
| 04711605587969 | Dual offset broach handle, left |
| 04711605587952 | Offset broach handle |
| 04711605587945 | Straight broach handle |
| 04719872146049 | Angled broach handle |
| 04719872145585 | Calcar reamer, large |
| 04719872145301 | Dual offset broach handle, left |
| 04719872143277 | Dual offset broach handle, right |
| 04719872143260 | Dual offset broach handle, left |
| 04719872143147 | Offset broach handle |
| 04719872143130 | Stem extractor, anterior |
| 04719872142843 | Smooth canal finder |
| 04719872142393 | Neck template |
| 04719886894509 | Calcar reamer, Ø35mm |
| 04719886896176 | Sharp broach, #11 |
| 04719886896169 | Sharp broach, #10 |