Integra®
Integra® Surgical Instruments The pin puller is used to slide over objects that have been drilled into the bone, such as k-wires, grasped and pulled out of the bone.
53manufacturers in China registered for this device type
47catalogue 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 | 2017-08-30 |
| Record revised | 2024-09-11 (version 9) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 4.52 to 8.7 in; width 2.5 in |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLP1002519 | 290 mm L | In distribution |
| 5010001 | 65mm L x 12mm diameter | In distribution |
| G207153 | 4.52 in L | In distribution |
| TRQ092008601 | Length 4.52 in | In distribution |
| PBH80001 | Size Small; 7.03 in L x.070 in L thread | In distribution |
| SDGTFS25 | 44.92 mm L x 2.8 mm inner dia | In distribution |
| 238500 | In distribution | |
| LIGTFS18 | 1.3 in L x.91 in W | In distribution |
| ADP90001 | 3.0 in L x.356 in dia | In distribution |
| G107992B | Length 7.13 in | In distribution |
| ADP90002 | 3.0 in L x.406 in dia | In distribution |
| PUL092008701 | 140mm L x 11mm W | In distribution |
| CDGTFS18 | 29.9 mm L x 2.03 mm inner dia | In distribution |
| 12224300 | In distribution | |
| 12225315 | 2.56 in L | In distribution |
| SDGTFS27 | 30.57 mm L x 2.98 mm inner dia | In distribution |
| 12225040 | 6.883 in L | In distribution |
| PBH80000 | Size Large; 7.03 in L x.095 in L thread | In distribution |
| PBI80000 | 4.72 in L x.55 in W | In distribution |
| 225205KMI | In distribution | |
| LDGTFS25 | 43.9 mm L | In distribution |
| MAL092008501 | 8.7 in L x 2.5 in W | In distribution |
| 12224508 | 222.7 mm L | In distribution |
| MHT-LGTHT | In distribution | |
| LDGTFS18 | 28.7 mm L | In distribution |
| EXT35000 | NA | In distribution |
| IMP35001 | 3.0 in dia x 1.0 in depth | In distribution |
| 12225060 | 5.702 in L | In distribution |
| NR135004J004 | 4.5 in L x 3.88 in W | In distribution |
| 12225050 | 6.238 in L | In distribution |
| 12224507 | 187 mm L | In distribution |
| 382000 | 179mm L x 8mm H x 89mm W | In distribution |
| SDGTFS35 | 45.28 mm L x 3.78 mm inner dia | In distribution |
| A3020 | 140mm L x 47mm H (suspended arm) | In distribution |
| RIGTFS18 | 1.3 in L x.91 in W x.75 in H | In distribution |
| 5010001000 | 4.399 in L handle | In distribution |
| G108404B | In distribution | |
| 2204157 | 139.1 mm L | In distribution |
| ADP90003 | 3.0 in L x.456 in dia | In distribution |
| SDGTFS18 | 30.18 mm L x 2.03 mm inner dia | In distribution |
| 12225020001 | 4.388 in L x.235 in dia cannula; 3.036 in L handle | In distribution |
| RM1011S03 | 5.51 in L | In distribution |
| 12225300 | .004 in opening | In distribution |
| G107991B | 8.7 in L x 2.5 in W | In distribution |
| 12225020002 | 5.245 in L x.176 in dia | In distribution |
| 238000 | Withdrawn | |
| 503 004249 | 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.