← Back to catalogue
Skyline Anterior Cervical Plate System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 186801016SModel SKYLINE Anterior Cervical Plate System PlatesRef 186852024SModel SKYLINE Anterior Cervical Plate System ScrewsRef 186804088SRef 186860015SRef 186850013SRef 186852022SRef 186852010SRef 186803039SRef 186805085SRef 186852017SRef 186850015SRef 186862010SRef 186803036SRef 186852013SRef 186852015SRef 186803036Ref 186803066Ref 286880003Model Cases and Trays for Spinal Medical DevicesRef 186860015Ref 186802032Ref 186805095SRef 186802036SRef 186852026Ref 186850012SRef 186804064SRef 186804084SRef 186802028Ref 286820014Model Skyline Orthopaedic Surgery Cutting InstrumentsRef 186852017Ref 286820016Ref 186864012
Identity
- Trade Name
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EUDAMEDSKYLINE FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDIFluted surgical drill bit, reusable FDA UDISpinal bone screw, non-bioabsorbable FDA UDIInstrument tray, reusable FDA UDI
- Device Name
- Plates EUDAMEDScrews EUDAMEDCases and Trays for Spinal Medical Devices EUDAMEDSkyline Drill EUDAMEDSKYLINE ANTERIOR CERVICAL PLATE SYSTEM FOUR LEVEL PLATE 64mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 36mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 16mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 32mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 16mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 17mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SCREW CADDY FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 12mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 12mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 28mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-DRILLING SCREW 4 x 15mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 36mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 14mm FDA UDI
- Model / Reference
- SKYLINE Anterior Cervical Plate System Plates EUDAMED186801016S EUDAMEDFDA UDISKYLINE Anterior Cervical Plate System Screws EUDAMED186852024S EUDAMED186804088S EUDAMED186860015S EUDAMED186850013S EUDAMED186852022S EUDAMED186852010S EUDAMED186803039S EUDAMED186805085S EUDAMED186852017S EUDAMED186850015S EUDAMED186862010S EUDAMED186803036S EUDAMED186852013S EUDAMED186852015S EUDAMED186804064S EUDAMEDFDA UDI186802036S EUDAMEDFDA UDI286820016 EUDAMEDFDA UDI186852026 EUDAMEDFDA UDI186802032 EUDAMEDFDA UDI186803066 EUDAMEDFDA UDI186852017 EUDAMEDFDA UDI286880003 EUDAMEDFDA UDI186864012 EUDAMEDFDA UDI186850012S EUDAMEDFDA UDI186802028 EUDAMEDFDA UDI186860015 EUDAMEDFDA UDI186803036 EUDAMEDFDA UDI286820014 EUDAMEDFDA UDICases and Trays for Spinal Medical Devices EUDAMED186805095S EUDAMED186804084S EUDAMEDSkyline Orthopaedic Surgery Cutting Instruments EUDAMED
- Description
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FOUR LEVEL PLATE 64mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 36mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 16mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 32mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 16mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 17mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SCREW CADDY FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 12mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 12mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 28mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-DRILLING SCREW 4 x 15mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 36mm FDA UDISKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 14mm FDA UDI
Identifiers
- Catalog Number
- 186804064S FDA UDI186802036S FDA UDI286820016 FDA UDI186852026 FDA UDI186802032 FDA UDI186801016S FDA UDI186803066 FDA UDI186852017 FDA UDI286880003 FDA UDI186864012 FDA UDI186850012S FDA UDI186802028 FDA UDI186860015 FDA UDI186803036 FDA UDI286820014 FDA UDI
- Primary DI / UDI-DI
- 10705034411859 EUDAMEDFDA UDI10705034412580 EUDAMED10705034412238 EUDAMED10705034412726 EUDAMED10705034412368 EUDAMED10705034412566 EUDAMED10705034412443 EUDAMED10705034412054 EUDAMED10705034412283 EUDAMED10705034412511 EUDAMED10705034412382 EUDAMED10705034412788 EUDAMED10705034412047 EUDAMED10705034412474 EUDAMED10705034412498 EUDAMED10705034412177 EUDAMEDFDA UDI10705034411996 EUDAMEDFDA UDI10705034215327 EUDAMEDFDA UDI10705034134352 EUDAMEDFDA UDI10705034133683 EUDAMEDFDA UDI10705034133850 EUDAMEDFDA UDI10705034134260 EUDAMEDFDA UDI10705034215532 EUDAMEDFDA UDI10705034134734 EUDAMEDFDA UDI10705034412351 EUDAMEDFDA UDI10705034133669 EUDAMEDFDA UDI10705034134505 EUDAMEDFDA UDI10705034133751 EUDAMEDFDA UDI10705034215310 EUDAMEDFDA UDI10705034412306 EUDAMED10705034412221 EUDAMED
- Basic UDI-DI
- 0705034a002215N EUDAMED0705034a002225Q EUDAMED0705034a0001159 EUDAMED0705034a0009467 EUDAMED
- Direct Marketing DI
- 10705034215532 EUDAMED10705034215310 EUDAMED10705034215327 EUDAMED
- FDA Product Code
- KWQ FDA UDIHTW FDA UDIFSM FDA UDI
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMEDV0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMEDZ12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDIFluted surgical drill bit, reusable FDA UDISpinal bone screw, non-bioabsorbable FDA UDIInstrument tray, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDFDA UDIClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Cervical spine immobilization system, single-use
Skyline Anterior Cervical Plate System by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PMT® Halo Systems — Pmt Corp. · Class II
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- TST Spinal System — TST RAKOR VE TIBBİ ALETLER SAN.VE TİC.LTD.ŞTİ. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002215N | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (46)
- EUDAMED c3514c78-0003-422e-9a85-19e84036386e 61 fields · synced Aug 3, 2026
- EUDAMED 67a2c19c-258e-4108-951d-b8bbafe7fe58 61 fields · synced May 16, 2026
- EUDAMED 96904775-120e-490a-a8b3-81ff7e859f0b 61 fields · synced May 16, 2026
- EUDAMED 07d8c5c6-83ab-497a-b658-8bb630175bbb 61 fields · synced May 16, 2026
- EUDAMED 686a297a-8bd4-49df-ae1b-b54733ba0125 61 fields · synced May 16, 2026
- EUDAMED 56d9fc11-1f9a-4f99-8b86-716548da4652 61 fields · synced May 17, 2026
- EUDAMED 20cd2cfd-c05e-4ce8-80aa-0edad988bd03 61 fields · synced May 17, 2026
- EUDAMED 715a9746-e189-4e32-ad2e-ceaf493a8a94 61 fields · synced May 17, 2026
- EUDAMED 07d01a10-154c-4eae-a96d-a494074debae 61 fields · synced May 17, 2026
- EUDAMED c77bf88a-d80d-47fc-8475-a7349d925f95 61 fields · synced May 18, 2026
- EUDAMED ecfa2db4-3418-43a3-b9fb-fc4dcffeb69b 61 fields · synced May 18, 2026
- EUDAMED b4b18908-48af-4598-97e3-56b3d1d787f5 61 fields · synced May 18, 2026
- EUDAMED 2c294466-f1c3-4bc8-b98b-fd05a1aadc2b 61 fields · synced May 18, 2026
- EUDAMED c6fe76c9-0044-4603-b0e9-53f05528cbc0 61 fields · synced May 18, 2026
- EUDAMED c37d1094-3f99-4854-9fae-84d0e577f5e2 61 fields · synced May 18, 2026
- FDA UDI 9708f843-eab0-470f-b623-6e48623cbbfd 36 fields · synced May 29, 2026
- FDA UDI a59f34a4-3fe8-4d87-82e9-1a75367af277 36 fields · synced May 29, 2026
- FDA UDI 967d9b9e-1026-4015-bccc-854ad909c5f6 35 fields · synced May 30, 2026
- FDA UDI 8ef6c2b4-926d-4b02-89a7-e7b07d8d55c5 36 fields · synced May 30, 2026
- FDA UDI 4a144fbf-fdf0-4a28-9360-f3c09bc965f0 36 fields · synced May 30, 2026
- FDA UDI cfef3968-272d-4144-9a72-f3ab62b1fc46 36 fields · synced May 30, 2026
- FDA UDI 9dfb631e-3b8d-49e6-99b4-b10b4db1ff3f 36 fields · synced May 30, 2026
- FDA UDI daf3b60c-6bd1-473d-83d6-498c4dee23b9 36 fields · synced May 30, 2026
- FDA UDI e87034f9-6e15-439e-b629-8205192a204b 35 fields · synced May 30, 2026
- FDA UDI 68bb403b-013f-4a11-94c8-57a991c595f1 36 fields · synced May 30, 2026
- FDA UDI 48dd86cb-8595-4fc2-b1e7-6b5d23349be7 36 fields · synced May 30, 2026
- FDA UDI c8360a0f-4c6d-4949-9a12-6069cbecd57d 36 fields · synced May 30, 2026
- FDA UDI b1855843-0461-4869-9954-47eb85b3adee 36 fields · synced May 30, 2026
- FDA UDI faa02c6c-0622-483f-9a2d-3626f7d0118b 36 fields · synced May 30, 2026
- FDA UDI ad6cc02d-156a-48ae-9220-0820e4181aff 35 fields · synced May 30, 2026
- EUDAMED af18e60b-284e-4034-8989-1203176787b8 61 fields · synced Jun 20, 2026
- EUDAMED 620e9c2a-990a-4857-a4a2-99a342617b67 61 fields · synced Jun 20, 2026
- EUDAMED 0c6d5d10-5a69-49d2-b6ad-9e886e199117 61 fields · synced Jul 8, 2026
- EUDAMED 8f1498c9-a746-48a1-a8ac-61047f05e473 61 fields · synced Jul 9, 2026
- EUDAMED c15be8af-c498-4300-8406-7fd4d8c6c016 61 fields · synced Jul 9, 2026
- EUDAMED 514240cd-9240-4734-a913-0c7b56cf6389 61 fields · synced Jul 9, 2026
- EUDAMED a2e3bc5f-d60d-4eca-84eb-1ff26d52b031 61 fields · synced Jul 9, 2026
- EUDAMED 83e92d7e-a782-40a4-83ba-154dcc278a72 61 fields · synced Jul 9, 2026
- EUDAMED b57ada8a-9b12-4377-b045-02185d610a3c 61 fields · synced Jul 21, 2026
- EUDAMED 782ce5df-cbc5-497a-9983-965153c940ac 61 fields · synced Jul 24, 2026
- EUDAMED 067711fb-9d12-4a15-a39f-8823fd227e24 61 fields · synced Jul 26, 2026
- EUDAMED c4a1a72a-5471-472e-a5f6-776834913cc5 61 fields · synced Jul 28, 2026
- EUDAMED 624871c4-3241-4126-81ec-a114518abfad 61 fields · synced Jul 29, 2026
- EUDAMED b5ac198a-2a4c-4d72-ad58-72d94283c11b 61 fields · synced Jul 29, 2026
- EUDAMED ac808c13-85cd-4a5d-8a79-16a444a7c188 61 fields · synced Aug 3, 2026
- EUDAMED f372f621-3432-4b3f-b57c-247e7842f06a 61 fields · synced Aug 3, 2026