Integra® Spider™ Limted Wrist Fusion System
- Primary DI
- M248SPIDERIMP1
- Brand
- Integra® Spider™ Limted Wrist Fusion System
- Company
- Ascension Orthopedics, Inc.
- Model
- SPIDERIMP
- Catalog number
- SPIDERIMP
- Device description
- SPIDER Implant Set
- Published
- 2018-05-11
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| HRS | Plate, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K991873 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780441373 | Primary | GS1 | 0 | |
| M248SPIDERIMP1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780441373 | 10381780441373 |
GMDN Terms#
| Term | Definition |
|---|---|
| Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile | A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780240204 | Cadence™ | 10203022 | 2016-08-24 | |
| 10381780240211 | Cadence™ | 10203023 | 10203023 | 2016-08-24 |
| 10381780240228 | Cadence™ | 10203024 | 10203024 | 2016-08-24 |
| 10381780240235 | Cadence™ | 10203025 | 2016-08-24 | |
| 10381780240242 | Cadence™ | 10203026 | 2016-08-24 | |
| 10381780240754 | Cadence™ | 10204202 | 10204202 | 2016-08-24 |
| 10381780245612 | Titan™ | IMC096004301 | IMC-0960-043-01 | 2017-08-30 |
| 10381780246374 | Integra® | OSG20000 | OSG-200-00 | 2017-08-30 |
| 10381780246381 | Integra® | OSG20010P | OSG-200-10P | 2017-08-30 |
| 10381780246398 | Integra® | OSG20010PV | OSG-200-10PV | 2017-08-30 |
| 10381780246404 | Integra® | OSG20020P | OSG-200-20P | 2017-08-30 |
| 10381780246411 | Integra® | OSG20020PV | OSG-200-20PV | 2017-08-30 |
| 10381780246428 | Integra® | OSG20030P | OSG-200-30P | 2017-08-30 |
| 10381780246435 | Integra® | OSG20030PV | OSG-200-30PV | 2017-09-05 |
| 10381780246442 | Integra® | OSG20040P | OSG-200-40P | 2017-09-05 |
| 10381780246459 | Integra® | OSG20040PV | OSG-200-40PV | 2017-08-30 |
| 10381780246466 | Integra® | OSG35001 | OSG-350-01 | 2017-08-30 |
| 10381780246473 | Integra® | OSG44200 | OSG-442-00 | 2017-09-05 |
| 10381780246480 | First Choice® DRUJ System | OSG60000 | OSG-600-00 | 2017-09-05 |
| 10381780246497 | First Choice® DRUJ System | OSG60001 | OSG-600-01 | 2017-09-05 |
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