Specials

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Specials FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: MIS NAV Tap, 5.5mm FDA UDI
Model / Reference: SR-0979-55 FDA UDI
Description: MIS NAV Tap, 5.5mm FDA UDI

Identifiers

Catalog Number: SR-0979-55 FDA UDI
Primary DI / UDI-DI: 10889981305567 FDA UDI
510(k) Number: K191648 FDA UDI
FDA Product Code: NKB FDA UDI
OLO FDA UDI
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone tap, reusable

Specials by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone tap, reusable.

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Insite — TORNIER, INC. · Class I
ReLine — Nuvasive, Inc. · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
Nautilus Spinal System — Life Spine, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 3d9390fc-af55-4db0-8109-ed95ad48c4ca 36 fields · synced Jun 8, 2026