Titan™
Titan™ Total Shoulder System The glenoid peg punch is used to check hole positioning/depth, in addition to being used as a cement pressurizer. The glenoid peg punch can be utilized to…
Titan™ Total Shoulder System The glenoid peg punch is used to check hole positioning/depth, in addition to being used as a cement pressurizer. The glenoid peg punch can be utilized to impact the graft.
53manufacturers in China registered for this device type
84catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-05 |
| Record revised | 2024-09-11 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 5.5 in |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS0920071LRG | Large | In distribution |
| IMP-0961-064-S | S | In distribution |
| SR0920066001 | 5.5 in L x.176 in tip dia | In distribution |
| HDL096006701 | 10.4 in x.255in diameter | In distribution |
| IS0920071SML | Small | In distribution |
| HDL-0926-001 | 3.4 in L rod | In distribution |
| HR0920063001 | In distribution | |
| CVR0920076S | 1.40 in L x 1.20 in W; Small | In distribution |
| ROD-0923-040-001 | 6.23 in L x.19 in dia | In distribution |
| RMR-0961-076-S | S | In distribution |
| PEG-0926-000 | 1.13 in L | In distribution |
| BSH-0923-048-001 | Size XS-S; 1.14 in H | In distribution |
| CVR0920076L | 1.75 in L x 1.50 in W; Large | In distribution |
| PEG096007301 | .79 in L x.307 in dia | In distribution |
| IMS096007001 | 2.2 in H | In distribution |
| PN0920062002 | Size Medium/Large; 1.45 in L x 1.06 in W punch | In distribution |
| BH0920048002 | Size M-L; 1.19 in H | In distribution |
| DRG092206702 | Size Medium/Large | In distribution |
| TRL-0961-02C-S | S | In distribution |
| TRL-0961-02E-S | S | In distribution |
| DGB096008SML | Size Small | In distribution |
| SS0920054001 | 4.0 in L x 2.50 in W x 1.0 in H | In distribution |
| SET189D007 | 6.0 in L x.095 in W | In distribution |
| SCR096007201 | 9.80 in L | In distribution |
| HDR-0940-048-001 | 9.9 in L | In distribution |
| INS-0961-049-01 | In distribution | |
| TMP-0961-01L | 142.5 Left | In distribution |
| TT0920044001 | 4.0 in L x 1.0 in H | In distribution |
| ADP-0980-105-00 | 8.13 in L x.275 in dia | In distribution |
| INS-0961-048-01 | In distribution | |
| SET188A001 | In distribution | |
| GWG096005301 | 7.0 in L handle | In distribution |
| SCR-0961-063-01 | Length 5.5 in | In distribution |
| INS096004902 | 1.925 in L x.550 in major dia | In distribution |
| DG0920049002 | Size Medium/ Large | In distribution |
| DG0920049001 | Size X-Small/ Small | In distribution |
| SCR-0961-065-01 | Length 5.5 in | In distribution |
| DRL-0961-054-S | S | In distribution |
| BH0920048001 | .55 in L x.083 in dia | In distribution |
| HDL092208201 | In distribution | |
| CSA-0961-01 | In distribution | |
| HDL-0926-002 | 5.20 in L x 4.50 in W | In distribution |
| GWG0960050EL | 7.0 in L handle | In distribution |
| AT0920065001 | .60 in L x.32 in dia | In distribution |
| PN0920072002 | Size Medium/Large; 1.45 in L x 1.06 in W punch | In distribution |
| GWG0960050CL | 7.0 in L handle | In distribution |
| ADT-0923-065-001 | .765 in L | In distribution |
| HL0920043001 | 6.35 in L | In distribution |
| HDL-0961-067-S | S | In distribution |
| DDG-0961-077-S | S | In distribution |
| RGB096008STD | Standard | In distribution |
| RGB096008SML | Small | In distribution |
| IMC096004301 | 2.06 in L | In distribution |
| HL0920075001 | 8.5 in L | In distribution |
| AA0950040502 | 3.9 in L x.450 in dia | In distribution |
| DGB096008STD | Size Standard | In distribution |
| CSA-0961-02 | In distribution | |
| TRL-0961-05E-S | S | In distribution |
| RD0920040002 | 6.23 in L x.19 in dia | In distribution |
| RDG-0961-078 | 4.5mm | In distribution |
| AA0950040501 | 3.9 in L x.450 in dia | In distribution |
| HDL096006501 | 9.8 in L | In distribution |
| BDG-0961-074-S | S | In distribution |
| PN0920072001 | Size X-Small/ Small; 1.25 in L x.90 in W punch | In distribution |
| SCR096006301 | 5.5 in L | In distribution |
| TRL-0961-05C-S | S | In distribution |
| CVR0920077L | 1.50 in L x 1.75 in W; Large | In distribution |
| CVR0920077S | 1.20 in L x 1.40 in W; Small | In distribution |
| SD0920071001 | 5.16 in L x 4.26 in H | In distribution |
| RGB096008LRG | Large | In distribution |
| DRG092206701 | Size X-Small/ Small | In distribution |
| PN0920062001 | Size X-Small/ Small; 1.25 in L x.90 in W punch | In distribution |
| PEG092207402 | In distribution | |
| IS0920071STD | Standard | In distribution |
| BDG096007401 | 7mm L x.10mm H x.60mm W;.360mm L x.04542mm diameter arm | In distribution |
| DGB096008LRG | Size Large | In distribution |
| RMR-0961-075-S | S | In distribution |
| TMP-0961-01R | 142.5 Right | In distribution |
| TITANBOWTIEIMP | Withdrawn | |
| PUN-0940-043-000 | 8.9 in L | Withdrawn |
| SCR-0961-073-01 | Length 5.5 in | Withdrawn |
| PUN-0940-043-001 | Size Small; 8.9 in L | Withdrawn |
| TITANREVSPBIMP | Withdrawn | |
| PUN-0940-043-002 | Size Large; 8.9 in L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
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.